Effects of Sodium Concentration and Dialysate Temperature Changes on Blood Pressure in Hemodialysis Patients: A Randomized, Triple-Blind Crossover Clinical Trial


Ebrahimi, H.; Safavi, M.; Saeidi, M.Hossein.; Emamian, M.Hassan.

Therapeutic Apheresis and Dialysis 21(2): 117-125

2017


The present study investigated the effects of different temperatures and sodium dialysate concentration on blood pressure in hemodialysis patients. Following Williams' design, hemodialysis patients were randomly assigned into four dialysis modes. Dialysate temperature was set at 37°C for modes A and C and, 35°C for modes B and D. Sodium concentration was set at 138 mmol/L in modes A and B, while it changed from 150 mmol/L to 138 mmol/L in modes C and D. Using analysis of variance for repeated measures, the mean values of systolic and diastolic blood pressure were investigated. The mean values of systolic and diastolic blood pressure in modes C and D had a significant difference with the values in mode A. The mean values of systolic and diastolic blood pressure in patients dialyzed with mode B had a significant difference with the values in those dialyzed with mode D. Moreover, there were significant differences in the incidence of hypotension between A and other modes and between B and modes C and D, but this difference was not significant between modes C and D. In order to reduce intradialytic blood pressure fluctuations and hypotension, the nursing staff are recommended to gradually reduce dialysate sodium concentration.

Therapeutic
Apheresis
and
Dialysis
Therapeutic
Apheresis
and
Dialysis
2017;
21(2):117-125
doi:
10.1111/1744-9987.12506
©
2017
International
Society
for
Apheresis,
Japanese
Society
for
Apheresis,
and
Japanese
Society
for
Dialysis
Therapy
Effects
of
Sodium
Concentration
and
Dialysate
Temperature
Changes
on
Blood
Pressure
in
Hemodialysis
Patients:
A
Randomized,
Triple-Blind
Crossover
Clinical
Trial
Hossein
Ebrahimi,
1
Mahboobeh
Safavi,
2
Marzieh
Hossein
Saeidi,
3
and
Mohammad
Hassan
Emamian
4
1
Randomized
Controlled
Trial
Research
Center,
Shahroud
University
of
Medical
Sciences,
Shahroud,
and
2
Department
of
Nursing
and
Midwifery,
Islamic
Azad
University
of
Tehran,
Tehran,
3
Damghan
Vellayate
Hospital,
Semnan
University
of
Medical
Sciences,
Semnan,
4
Center
for
Health
Related
Social
and
Behavioral
Sciences
Research,
Shahroud
University
of
Medical
Sciences,
Shahroud,
Iran
Abstract:
The
present
study
investigated
the
effects
of
different
temperatures
and
sodium
dialysate
concentration
on
blood
pressure
in
hemodialysis
patients.
Following
Williams'
design,
hemodialysis
patients
were
randomly
assigned
into
four
dialysis
modes.
Dialysate
temperature
was
set
at
37°C
for
modes
A
and
C
and,
35°C
for
modes
B
and
D.
Sodium
concentration
was
set
at
138
mmol/L
in
modes
A
and
B,
while
it
changed
from
150
mmol/L
to
138
mmol/L
in
modes
C
and
D.
Using
analysis
of
variance
for
repeated
measures,
the
mean
values
of
systolic
and
diastolic
blood
pressure
were
investigated.
The
mean
values
of
systolic
and
diastolic
blood
pressure
in
modes
C
and
D
had
a
significant
difference
with
the
values
in
mode
A.
The
mean
values
of
systolic
and
diastolic
blood
pressure
in
patients
dialyzed
with
mode
B
had
a
significant
difference
with
the
values
in
those
dialyzed
with
mode
D.
Moreover,
there
were
significant
differences
in
the
incidence
of
hypo-
tension
between
A
and
other
modes
and
between
B
and
modes
C
and
D,
but
this
difference
was
not
significant
between
modes
C
and
D.
In
order
to
reduce
intradialytic
blood
pressure
fluctuations
and
hypotension,
the
nursing
staff
are
recommended
to
gradually
reduce
dialysate
sodium
concentration.
Key
Words:
Blood
pressure,
Dialysate
sodium,
Dialysate
temperature,
Dialysis,
Renal
failure.
Chronic
kidney
disease
(CKD)
is
a
pathophysio-
logical
process
with
various
causes.
It
inevitably
leads
to
a
reduction
in
the
number
and
functioning
of
nephrons
and
consequently
results
in
end-stage
renal
disease
(ESRD)
(1).
ESRD
disturbs
the
body's
abil-
ity
to
maintain
fluid
and
electrolyte
balance
in
the
blood.
Also
it
weakens
the
process
of
eliminating
other
nitrogenous
waste
products
from
the
blood,
leading
to
uremia
or
azotemia.
The
disease
often
remains
unknown
even
in
those
suffering
from
it,
because
of
the
asymptomatic
nature
of
CKD
(2).
In
the
United
States,
the
prevalence
of
CKD
treated
with
dialysis
and
transplantation
increased
from
10%
during
1994-1998
to
13.1%
during
1999-2004
(3).
In
a
population-based
study
in
Tehran,
Iran,
the
Received
February
2016;
revised
August
2016.
Address
correspondence
and
reprint
requests
to
Marzieh
Hossein
Saeidi,
M.Sc,
Vellayate
hospital,
Semnan
University
of
Medical
Sciences,
Damghan,
Iran.
Email:
parisan.saeidi@yahoo.com
age-adjusted
prevalence
of
CKD
in
a
population
aged
20
years
and
above
was
reported
14.9%;
such
a
high
prevalence
is
considered
as
a
serious
threat
to
health
(4).
Hemodialysis
(HD)
is
the
most
common
choice
for
patients
with
ESRD
(5).
Despite
the
remarkable
progress
made
in
different
fields
of
nephrology,
there
is
no
alternative
for
dialysis
before
kidney
transplan-
tation.
So
HD
has
become
the
most
common
mainte-
nance
therapy
for
patients
with
CKD
over
the
past
few
decades
(6).
Dialysis
is
performed
to
prevent
dangerous
complications
including
uremia,
electro-
lyte
imbalance,
and
pericarditis.
According
to
the
International
Renal
Care
Center,
it
is
estimated
that
more
than
one
million
medical
staff
will
be
required
to
take
care
of
approximately
1.4
million
people
receiving
dialysis
in
2020
(7).
Improvement
of
patients
undergoing
HD
depends
on
not
only
medicines
(8)
but
also
diet
and
fluid
restrictions
(9).
Failure
to
comply
with
such
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1.
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at
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118
H
Ebrahimi
et
al.
restrictions
is
associated
with
complications
such
as
fluid
retention,
accumulation
of
toxic
substances,
cardiovascular
problems,
and
ultimately
premature
death
(8).
Although
dialysis
is
very
effective
in
the
removal
of
soluble
compounds
and
excess
fluids,
it
is
often
associated
with
side
effects
such
as
hypoten-
sion,
muscle
cramps,
dizziness,
and
lightheadedness
(10).
Intradialytic
hypotension
is
a
common
compli-
cation
(11)
which
occurs
among
20-30%
of
patients
(12).
Because
of
patients'
intolerance,
intradialytic
hypotension
not
only
limits
the
removal
of
excess
fluid,
but
it
may
also
result
in
complications
such
as
cardiac
ischemia
and
cerebral
infarction
(13).
Differ-
ent
approaches
can
be
adopted
for
prevention
and
treatment
of
intradialytic
hypotension.
Some
studies
have
shown
that
cold
dialysis
improves
patients'
cardiovascular
tolerance
and
reduces
the
signs
and
symptoms
of
hypotension
(11,13,14).
Using
appropri-
ate
sodium
concentration
is
another
method
pro-
posed
for
prevention
of
intradialytic
hypotension.
This
method
is
started
with
the
administration
of
a
hypernatremic
dialysate,
and
then
the
amount
of
sodium
is
reduced
to
remove
excess
sodium
added
to
the
patient's
blood
during
dialysis
(15).
Ultrafiltra-
tion
(UF)
is
another
method
of
hypotension
preven-
tion.
In
this
method,
the
dialysis
machine
is
set
to
take
more
fluid
from
the
patient
at
the
beginning
of
dialysis
and
less
in
the
final
stages.
At
the
end
of
dialysis,
UF
reduction
can
prevent
the
occurrence
of
hypotension
(16).
Some
studies
suggested
a
combination
of
sodium
concentration
and
UF
for
prevention
of
intradialytic
hypotension
(14,15,17,18).
Despite
the
availability
of
different
prevention
methods,
the
rate
and
frequency
of
intradialytic
hypotension
did
not
change.
On
the
other
hand,
to
the
best
of
the
authors'
knowledge,
no
study
is
available
regarding
the
combination
of
dialysate
temperature
reduction
and
use
of
sodium
for
the
prevention
of
intradialytic
hypotension.
Therefore,
the
present
study
aimed
to
investigate
the
effects
of
changes
in
temperature
and
sodium
dialysate
on
blood
pressure
in
HD
patients.
PATIENTS
AND
METHODS
This
randomized,
triple-blind
crossover
clinical
trial
study
was
carried
out
according
to
Williams'
design
(Fig.
1).
The
study
population
consisted
of
110
patients
ad-
mitted
to
the
HD
ward
of
Emam
Hossein
Hospital,
the
only
referral
center
for
HD
patients
in
Shahroud,
a
city
located
in
northern
part
of
Iran.
The
main
inclusion
criteria
were
as
follows:
being
aged
18-75
years
old,
undergoing
HD
using
sodium
bicar-
bonate
solution
three
times
a
week,
having
a
history
of
at
least
6
months
of
HD
treatment,
and
having
©
2017
International
Society
for
Apheresis,
Ther
Apher
Dial,
Vol.
21,
No.
2,
2017
Japanese
Society
for
Apheresis,
and
Japanese
Society
for
Dialysis
Therapy
Effects
of
Changes
in
Sodium
Concentration
119
arteriovenous
fistula
vascular
access.
Other
inclusion
criteria
include:
not
suffering
from
severe
anemia
(hematocrit
levels
<20%)
(19)
or
coagulation
disorders
which
could
lead
to
bleeding
during
dialysis
(as
diagnosed
by
a
physician),
not
taking
high
blood
pressure
medications,
not
taking
any
blood
product
during
dialysis,
and
having
no
intention
for
migration
and
kidney
transplantation.
In
this
study,
death
of
patient,
serious
intradialytic
complications
such
as
seizures,
and
termination
of
dialysis
sooner
than
the
appointed
time
for
any
reason
were
considered
as
exclusion
criteria.
The
data
about
demographic
characteristics
of
the
patients
were
also
collected
from
their
medical
records.
Among
the
110
patients
treated
with
HD,
30
were
excluded
(24
patients
did
not
meet
the
inclusion
criteria
and
six
patients
declined
to
participate);
therefore,
the
remaining
80
patients
were
enrolled
in
the
study
after
obtaining
a
written
informed
con-
sent.
In
this
study,
four
protocols
were
administered
including:
dialysis
mode
A
(dialysate
temperature:
37°C;
routine
sodium
concentration:
138
mmol/L),
dialysis
mode
B
(dialysate
temperature:
35°C;
routine
sodium
concentration:
138
mmol/L),
dialysis
mode
C
(dialysate
temperature:
37°C;
sodium
dialysate
concentration
at
the
beginning
of
HD
was
150
mmol/L,
which
was
decreased
linearly
every
hour
until
it
reached
138
mmol/L
in
the
last
hour
of
the
dialysis),
and
dialysis
mode
D
(dialysate
temper-
ature:
35°C;
sodium
dialysate
concentration
at
the
beginning
of
HD
was
150
mmol/L,
which
was
decreased
linearly
every
hour
until
it
reached
138
mmol/L
in
the
last
hour
of
dialysis)
(11).
For
every
patient
in
this
study,
dialysis
via
each
of
the
treatment
modes
was
performed
in
three
sessions.
Dialyzer
and
the
duration
of
all
sessions
and
modes
of
dialysis
were
the
same
for
each
patient.
Moreover,
there
was
no
significant
difference
between
patients'
weight
gain
in
all
sessions
and
modes.
In
addition,
some
clinical
symptoms
of
patients
were
assessed
by
a
checklist
including
thirst,
chillness,
dizziness,
and
fatigue
in
all
sessions
and
modes.
Using
random
systematic
sampling
method,
the
participants
were
assigned
into
four
groups
of
20
pa-
tients
and
each
group
underwent
the
four
treatment
modes.
Following
Williams'
design,
the
orders
of
re-
ceiving
the
four
types
of
protocols
were
as
follows:
ADBC
for
the
first
group,
BACD
for
the
second
group,
CBDA
for
the
third
group,
and
DCAB
for
the
fourth
group.
Sodium
bicarbonate
dialysate
was
used
for
all
the
subjects.
Blood
flow
velocity
(the
pump
rate)
and
the
dialysate
flow
rate
were
set
at
200-300
mL/min
and
500
mL/min,
respectively.
The
subjects
blood
pressure
was
measured
via
a
standard
method
and
using
a
sphygmomanometer
at
five
time
intervals
(15
min
before
dialysis,
at
the
first,
second,
and
third
hour
of
dialysis,
and
15
min
after
dialysis);
it
was
measured
(by
the
second
author)
while
the
patient
was
in
the
supine
position.
In
order
to
prevent
central
pontine
myelitis,
which
might
occur
due
to
an
acute
change
in
serum
sodium
concentra-
tion,
the
concentration
of
sodium
dialysate
at
the
beginning
of
HD
was
set
at
150
mmol/L,
which
was
gradually
decreased
(1
mmol/L
every
15
min),
so
that
at
the
end
of
the
third
hour
of
dialysis
sodium
dialysate
concentration
reached
138
mmol/L
and
this
concentration
was
maintained
during
the
remaining
time
of
dialysis.
At
the
beginning
of
the
trial,
the
patients
were
ran-
domly
assigned
to
the
four
groups,
and
a
nurse
in
the
HD
ward
was
informed
and
trained
about
the
proce-
dures
and
arrangement
of
the
various
modes
of
HD
treatment.
Consistent
with
the
treatment
mode
selected
for
each
patient
group,
the
nurse
adjusted
the
temperature
and
the
concentration
of
dialysate
for
each
patient
in
each
session.
In
each
treatment
session,
the
patients
were
not
aware
of
the
dialysis
mode,
and
the
researcher
was
in
charge
of
measuring
and
recording
blood
pressure.
The
data
collector
and
the
data
analyzer
were
also
unaware
of
this
process.
In
order
to
increase
the
accuracy
of
each
treatment
mode,
one
week
of
washout
period
was
scheduled
during
routine
dialysis.
The
blood
pressure
measurements
in
all
groups
at
different
time
points
were
reported
as
the
mean
±
standard
deviation
(mean
systolic
and
diastolic
blood
pressure
measured
at
different
time
points
for
the
three
dialysis
sessions).
Following
the
European
Best
Practice
Guidelines
(EBPG)
definition,
intradialytic
hypotension
was
de-
fined
as
a
decrease
in
SBP
>20
mm
Hg
or
a
decrease
in
mean
arterial
pressure
(MAP)
by
>10
mm
Hg
when
it
is
associated
with
a
clinical
event
and
the
need
for
nursing
interventions
(20).
The
mean
systolic
and
diastolic
blood
pressure
and
intradialytic
hypotension
were
analyzed
through
analysis
of
variance
for
repeated
measures
and
post
hoc
tests.
The
generalized
estimating
equation
(GEE)
model
was
used
to
investigate
the
role
of
the
mode
of
treatment
and
group
variables
on
systolic
and
diastolic
blood
pressure
and
intradialytic
hypotension.
The
results
were
adjusted
for
sex,
age,
and
carryover
effect.
A
significance
level
of
0.5%
and
confidence
interval
of
95%
were
used
in
all
the
tests.
This
study
was
approved
by
the
ethics
committee
of
Shahroud
University
of
Medical
Sciences
(ethics
code:
06.920).
In
addition,
this
study
was
registered
©
2017
International
Society
for
Apheresis,
Japanese
Society
for
Apheresis,
and
Japanese
Society
for
Dialysis
Therapy
Ther
Apher
Dial,
Vol.
21,
No.
2,
2017
120
H
Ebrahimi
et
al.
in
the
Iranian
Registry
of
Clinical
Trials
(IRCT
code:
2013050613248
N1).
The
study
was
conducted
in
accordance
with
the
ethical
principles
regulated
by
the
Declaration
of
Helsinki
and
the
guidelines
of
the
Iranian
Ministry
of
Health
and
Medical
Education.
RESULTS
Of
all
the
study
participants,
55%
were
male
and
45%
were
female,
and
the
mean
age
of
the
patients
was
55.66
±
14.40
years.
Diabetes
mellitus
and
hyper-
tension
were
the
most
common underlying
disease
that
had
led
to
chronic
renal
failure
(Table
1).
In
this
study,
80
dialysis
sessions
were
carried
out
for
each
group,
and
the
results
of
320
dialysis
sessions
were
analyzed.
Dialysis
time
for
60
patients
was
3.5
h
and
for
20
patients
it
was
4
h
in
each
session.
According
to
the
study
results,
complications
such
as
thirst,
chillness,
dizziness,
and
fatigue
were
monitored
in
all
modes
and
no
significant
difference
was
seen
between
the
groups.
The
mean
systolic
and
diastolic
blood
pressure
un-
der
the
different
modes
of
A,
B,
C
and
D,
respec-
tively,
were
113.5/65.8,
116.5/67.9,
122.9/72.4,
125.1/
74.4
mm
Hg.
Comparing
the
changes
in
systolic
blood
pressure
of
the
patients
in
the
four
treatment
modes,
it
was
found
that
the
lowest
mean
blood
pressure
was
measured
in
mode
A
(dialysate
temperature:
37°C;
routine
sodium
concentration:
138
mmol/L).
In
other
words,
the
highest
hypoten-
sion
was
observed
in
the
routine
mode
and
the
mean
blood
pressure
was
higher
in
other
modes
(Table
2).
In
addition,
statistical
analysis
using
repeated
mea-
sures
showed
that
the
highest
and
lowest
values
of
the
mean
diastolic
blood
pressure
were
observed
in
the
treatment
protocols
D
and
A,
respectively.
Furthermore,
the
mean
diastolic
blood
pressure
was
more
stable
in
mode
D
than
in
the
other
modes
(Table
3).
Post
hoc
analysis
revealed
a
significant
difference
in
the
mean
systolic
blood
pressure
(mm
Hg)
between
mode
A
(113.51
±
20.30)
and
C
(122.94
±
20.30)
(P
=
0.021)
and
D
(125.16
±
20.30)
(P
=
0.002)
and
between
mode
B
(116.55
±
20.30)
and
D
(P
=
0.046).
Considering
the
mean
systolic
blood
pressure,
there
was
no
statistically
significant
difference
between
mode
B
and
A
(P
=
1.000)
and
C
(P
=
0.284)
and
between
mode
C
and
D
(P
=
1.000)
(Table
4).
According
to
the
results
of
the
post
hoc
analysis,
a
significant
difference
in
the
mean
diastolic
blood
pressure
(mm
Hg)
was
observed
between
mode
A
(65.88
±
9.94)
and
C
(72.41
±
9.94
mm
Hg)
(P
<
0.001)
and
D
(74.45
±
9.94)
(P
<
0.001)
and
between
mode
B
(67.97
±
9.94)
and
C
(P
=
0.026)
and
D
(P
<
0.001).
Considering
the
mean
diastolic
blood
pressure,
there
was
no
statistically
significant
difference
between
mode
B
and
A
(P
=
1.000)
and
between
mode
C
and
D
(P
=
1.000)
(Table
4).
Figures
2
and
3
show
the
changes
in
the
systolic
and
diastolic
blood
pressure
measured
at
different
time
points
and
in
different
modes.
In
the
GEE
model,
the
effect
of
the
treatment
modes
and
groups
on
systolic
blood
pressure
was
ex-
amined
with
respect
to
the
effects
of
sex
and
age.
As
shown
in
Table
5,
carryover
effect
(P
=
0.68)
and
group
(P
=
0.64)
had
no
effect
on
patients'
systolic
blood
pressure,
while
the
effects
of
various
treatment
methods
(dialysis
modes)
on
systolic
blood
pressure
were
significant
(P
=
0.001).
It
was
also
found
that
the
effect
of
age
on
blood
pressure
was
significant
(P
=
0.022)
(Table
5).
The
effects
of
sex
and
age,
the
effects
of
treatment
modes
and
groups
on
dia-
stolic
blood
pressure
were
also
examined
in
another
GEE
model.
As
shown
in
Table
5,
carryover
effect
(P
=
0.87)
and
group
(P
=
0.88)
had
no
effect
on
TABLE
1.
Characteristics
of
dialyzed
patients
Variables
Male
(n
=
44)
Female
(n
=
36)
Total
(N
=
80)
Mean
(SD)
Mean
(SD)
Mean
(SD)
Age,
years
57.34
(14.79)
55.83
(14.08)
56.66
(14.40)
Duration
of
HD
25.29
(13.11)
22.08
(13.73)
23.85
(15.08)
N
(%)
N
(%)
N
(%)
Diabetes
mellitus
24
(54.5)
22
(61.1)
46
(57.5)
Hyperlipidemia
8
(18.2)
1
(2.8)
9
(11.3)
Prior
cardiovascular
disease
1
(2.3)
3
(8.3)
4
(5)
Hypertension
24
(54.5)
25
(69.4)
49(61.25)
Cause
of
ESRD
Diabetes
mellitus
21
(47.7)
16
(44.4)
37
(46.3)
Hypertension
18
(40.9)
19
(52.8)
37
(46.3)
Diabetes
mellitus
&
hypertension
5
(11.4)
1
(2.8)
6
(7.5)
©
2017
International
Society
for
Apheresis,
Ther
Apher
Dial,
Vol.
21,
No.
2,
2017
Japanese
Society
for
Apheresis,
and
Japanese
Society
for
Dialysis
Therapy
TABLE
2.
Effects
of
Changes
in
Sodium
Concentration
The
mean
systolic
blood
pressure
of
dialyzed
patients
according
to
different
modes,
groups
and
times
121
SBP1
SBP2
SBP3
SBP4
SBP5
Mode
Group
Mean
SD
Mean
SD
Mean
SD
Mean
SD
Mean
SD
A
1
127.0
19.6
115.1
19.9
104.6
19.7
99.6
21.1
112.9
18.8
2
133.6
23.7 122.3
24.7
111.2
23.6
104.1
23.9
116.3
21.0
3
128.2
22.7
114.8
22.1
105.7
21.1
99.8
20.6
113.9
17.8
4
131.4
21.7
117.5
20.9
105.6
21.0
97.1
22.2
109.1
21.8
Total
130.1
21.7
117.4
21.8
106.8
21.1
100.1
21.7
113.1
19.7
B
1
136.1 22.5
127.0
22.9
121.1
24.1
117.6
24.8
126.8
21.9
2
128.0
22.4
115.7
20.9
106.4
19.1
101.2
20.8
111.4
21.1
3
123.5
18.9
114.6
21.4
107.2
20.5
104.2
21.2
116.5
19.7
4
126.8
22.5
116.5
21.4
107.1
20.4
105.1
20.2
116.9
17.7
Total
128.6
21.7
118.5
21.8
110.4
21.6
107.1
22.3
117.9
20.5
C
1
129.2
23.7
121.5
20.9
116.9
21.1
113.5
23.3
122.0
22.6
2
125.1
19.8
119.4
18.6
116.0
18.9
115.1
19.3
125.5
17.3
3
133.7
21.9
129.2
22.9
126.6
21.9
125.6
21.7
133.3
20.6
4
125.1
20.6
120.4
19.4
117.5
21.7
116.7
22.1
126.2
20.2
Total
128.2
21.4
122.6
20.5
119.2
21.1
117.7
21.7
126.7
20.3
D
1
123.5
19.9
118.8
17.9
119.0
18.4
120.1
19.0
129.9
17.8
2
119.5
21.1
117.1
18.6
118.7
19.2
119.6
20.8
126.3
20.0
3
134.1
23.4
126.3
23.0
121.9
22.6
119.8
24.1
126.6
23.9
4
135.5
21.8
130.2
20.7
129.0
21.4
129.2
21.3
137.7
19.8
Total
128.2
22.2
123.1
20.5
122.1
20.5
122.2
21.4
130.1
20.6
Total
1
128.9
21.6
120.6
20.6
115.4
21.5
112.7
23.1
122.9
21.0
2
126.5
22.0
118.6
20.6
113.1
20.5
110.0
22.2
119.9
20.5
3
129.9
21.8
121.2
22.9
115.3
23.1
112.3
24.1
122.6
21.7
4
129.7
21.6
121.1
20.9
114.8
22.8
112.1
24.3
122.5
22.3
total
128.8
21.7
120.4
21.2
114.6
21.9
111.8
23.4
121.9
21.3
A:
dialysate
temperature
37°C,
dialysate
sodium
138
mmol/L;
B:
dialysate
temperature
35°C,
dialysate
sodium
138
mmol/L;
C:
dialysate
temperature
37
°C
with
sodium
150
mmol/L
in
first
hour
of
dialysis
and
decreased
to
138
mmol/L
in
the
last
hour
of
dialysis;
D:
dialysate
temperature
35
°C
with
sodium
150
mmol/L
in
first
hour
of
dialysis
and
decreased
to
138
mmol/L
in
the
last
hour
of
dialysis;SBP1:
mean
systolic
blood
pressure
15
min
before
dialysis;
SBP2:
mean
systolic
blood
pressure
at
the
first
hour
during
dialysis;
SBP3:
mean
systolic
blood
pressure
at
the
second
hour
during
dialysis;
SBP4:
mean
systolic
blood
pressure
at
the
third
hour
during
dialysis;
SBP5:
mean
systolic
blood
pressure
15
min
after
dialysis.
diastolic
blood
pressure;
however,
the
effects
of
various
treatment
methods
(dialysis
modes)
on
diastolic
blood
pressure
were
significant
(P
<
0.001).
The
effect
of
age
on
blood
pressure
was
also
significant
(P
=
0.034)
(Table
5).
The
mean
incidence
of
intradialytic
hypotension
in
all
hemodialysis
sessions
and
in
different
modes
of
treatment
for
each
patient
was
7.16
(with
a
range
from
0
to
12).
The
mean
incidence
of
intradialytic
hypotension
in
modes
A,
B,
C
and
D
was
9.97,
8.42,
5.49,
and
4.74,
respectively
(P
<
0.001).
There
were
significant
differences
in
the
incidence
of
hypotension
between
A
and
other
modes
and
between
B
and
modes
C
and
D.
Although
the
incidence
of
intradialytic
hypotension
in
mode
D
was
lower
than
mode
C,
this
difference
was
not
significant
(Table
4).
The
GEE
model
examined
the
effect
of
the
various
treatment
modes
and
groups
on
the
incidence
of
intradialytic
hypotension
while
taking
into
account
the
effects
of
sex
and
age.
As
shown
in
Table
5,
the
effects
of
various
treatment
methods
(modes)
on
intradialytic
hypotension
was
significant
(P
<
0.001).
DISCUSSION
AND
CONCLUSION
In
the
present
study,
changes
in
systolic
and
diastolic
blood
pressure
in
patients
undergoing
HD
were
evaluated
using
four
treatment
modes.
The
results
showed
that
the
highest
rate
of
reduction
in
blood
pressure
and
intradialytic
hypotension
were
observed
in
the
routine
dialysis
mode
(dialysate
temperature:
37°C;
sodium
concentration:
138
mmol/L);
the
mean
values
of
blood
pressure
were
higher
in
other
modes.
Results
of
previous
studies
have
also
indicated
that
the
prevalence
of
hypotension
in
patients
undergoing
routine
HD
(dialysate
temperature:
37°C;
sodium
concentration:
138
mmol/L)
was
higher
than
in
those
undergoing
cold
dialysis
(11,13,21,22)
or
those
taking
sodium
concentration
(gradual
reduction
of
dialysate
sodium)
(17,23,24).
The
results
of
this
study
showed
that
patients
in
modes
D
(dialysate
temperature:
35°C;
sodium
dialysate
at
the
beginning
of
HD
was
150
mmol/L,
which
was
decreased
linearly
every
hour
until
it
reached
138
mmol/L
in
the
last
hour
of
dialysis)
and
C
(dialysate
temperature:
37°C;
sodium
dialysate
at
©
2017
International
Society
for
Apheresis,
Japanese
Society
for
Apheresis,
and
Japanese
Society
for
Dialysis
Therapy
Ther
Apher
Dial,
Vol.
21,
No.
2,
2017
122
H
Ebrahimi
et
al.
TABLE
3.
The
mean
diastolic
blood
pressure
of
dialyzed
patients
according
to
different
modes,
groups
and
times
Mode
Group
DBP1
DBP2
DBP3
DBP4
DBP5
Mean
SD
Mean
SD
Mean
SD
Mean
SD
Mean
SD
A
1
79.6
10.7
68.0
12.1
60.6
9.2
57.6
11.6
70.3
9.8
2
81.0
11.2
69.5
11.6
61.3
10.8
56.3
12.3
70.4
9.9
3
77.3
10.9
63.1
9.2
55.3
10.1
50.0
8.6
68.5
8.8
4
81.1
9.2
68.4
10.1
58.6
11.5
54.2
14.3
66.1
11.7
Total
79.7
10.5
67.2
10.8
59.0
10.5
54.5
12.1
68.8
10.1
B
1
82.3
12.3
71.4
10.9
66.5
10.8
66.0
12.2
76.4
10.4
2
79.8
11.4
67.5
10.5
59.9
10.7
57.1
13.8
69.0
10.6
3
75.3
10.2
68.0
11.4
62.5
10.2
59.0
11.9
71.0
10.6
4
76.1
12.7
65.1
12.4
56.6
10.1
56.8
11.1
71.3
8.9
Total
78.4
11.8
68.0
11.3
61.3
10.9
59.7
12.6
71.9
10.3
C
1
79.6
11.6
71.5
10.2
66.7
11.1
64.8
13.2
72.5
11.2
2
76.3
10.1
67.8
8.1
63.1
8.7
63.3
11.1
76.3
9.4
3
79.8
12.1
76.2
12.4
71.7
10.1
71.1
11.1
80.5
9.9
4
78.6
11.3
71.3
10.9
69.0
13.4
70.1
13.5
77.3
10.8
Total
78.6
11.1
71.7
10.7
67.6
11.2
67.3
12.5
76.6
10.5
D
1
75.0
11.3
68.1
10.3
68.0
10.7
68.3
12.4
77.5
8.9
2
76.0
10.1
71.8
12.3
72.6
12.1
73.5
11.7
79.5
12.2
3
82.3
10.3
72.6
10.1
70.1
11.8
68.1
11.9
76.0
11.5
4
81.5
10.9
77.2
8.8
73.5
7.7
74.1
10.5
83.0
7.9
Total
78.7
10.9
72.4
10.8
71.1
10.7
71.0
11.7
79.0
10.4
Total
1
79.1
11.6
69.7
10.8
65.4
10.6
64.2
12.8
74.2
10.3
2
78.2
10.7
69.1
10.7
64.2
11.6
62.5
13.9
73.8
11.2
3
78.7
11.1
70.0
11.7
64.9
12.3
62.1
13.6
74.0
11.1
4
79.3
11.1
70.5
11.3
64.4
12.8
63.8
14.9
74.4
11.6
total
78.8
11.1
69.8
11.1
64.7
11.8
63.1
13.8
74.1
11.1
A:
dialysate
temperature
37°C,
dialysate
sodium
138
mmol/L;
B:
dialysate
temperature
35°C,
dialysate
sodium
138
mmol/L;
C:
dialysate
temperature
37
°C
with
sodium
150
mmol/L
in
first
hour
of
dialysis
and
decreased
to
138
mmol/L
in
the
last
hour
of
dialysis;
D:
dialysate
temperature
35
°C
with
sodium
150
mmol/L
in
first
hour
of
dialysis
and
decreased
to
138
mmol/L
in
the
last
hour
of
dialysis;DBP1:
mean
diastolic
blood
pressure
15
min
before
dialysis;
DBP2:
mean
diastolic
blood
pressure
at
the
first
hour
during
dialysis;
DBP3:
mean
diastolic
blood
pressure
at
the
second
hour
during
dialysis;
DBP4:
mean
diastolic
blood
pressure
at
the
third
hour
during
dialysis;
DBP5:
mean
diastolic
blood
pressure
15
min
after
dialysis.
the
beginning
of
HD
was
150
mmol/L
which
was
decreased
linearly
every
hour
until
it
reached
138
mmol/L
in
the
last
hour
of
dialysis)
had
higher
mean
systolic
and
diastolic
blood
pressure
than
those
in
mode
A
(dialysate
temperature:
37°C;
sodium
con-
centration:
138
mmol/L),
and
this
difference
was
sta-
tistically
significant.
In
addition,
the
mean
systolic
and
diastolic
blood
pressures
were
significantly
higher
in
mode
D
than
in
mode
B
(dialysate
temper-
ature:
35°C;
sodium
concentration:
138
mmol/L).
Dheenan
and
Henrich
showed
that
the
incidence
of
intradialytic
hypotension
under
cold
dialysis
and
gradual
reduction
of
sodium
was
less
than
the
standard
method,
and
this
difference
was
statistically
significant.
But
intradialytic
hypotension
incidence
was
not
significantly
different
between
two
methods.
It
should
be
noted
that
this
study
has
not
evaluated
the
combination
of
cold
dialysis
and
gradual
reduc-
tion
of
sodium
(25).
In
the
study
by
Rezki
et
al.
(2007),
the
incidence
of
intradialytic
hypotension
in
patients
undergoing
cold
dialysis
method
as
well
as
the
combined
methods
of
cold
dialysis
and
gradual
reduction
of
sodium
was
lower
than
the
standard
method,
and
this
difference
was
statistically
significant.
However,
no
significant
difference
was
reported
between
the
standard
gradual
reduction
of
sodium
method,
cold
dialysis,
and
the
combined
methods
of
cold
dialysis
and
the
gradual
reduction
of
sodium
(14).
High
concentrations
of
sodium
dur-
ing
the
initiation
of
HD
facilitate
the
transfer
of
water
from
the
intercellular
space
to
extracellular
space
this
can
prevent
intradialytic
hypotension
via
maintaining
intravascular
volume
(15).
In
addition,
blood
pressure
increase
in
patients
dialyzed
with
cold
dialysate
is
due
to
an
increase
in
peripheral
vascular
resistance
and
vascular
tone
(21).
The
results
of
Rezki
et
al.
(2007)
are
consistent
with
the
results
of
this
study
in
terms
of
using
combination
therapy;
however,
they
are
inconsistent
using
the
cold
dialysis
and
gradual
reduction
of
sodium
methods
(14).
This
difference
could
be
due
to
differences
in
the
number
of
patients
and
some
underlying
diseases,
as
only
16
patients
were
evaluated
in
the
mentioned
study
and
44%
were
diagnosed
with
cardiomyopathy.
How-
ever,
80
patients
were
evaluated
in
the
present
study,
and
none
of
them
were
diagnosed
with
cardiomyopa-
thy
(14).
Shahgholian
et
al.
(2011)
showed
that
the
prevalence
of
hypotension
in
combination
dialysis
©
2017
International
Society
for
Apheresis,
Ther
Apher
Dial,
Vol.
21,
No.
2,
2017
Japanese
Society
for
Apheresis,
and
Japanese
Society
for
Dialysis
Therapy
95%
CI
P-
value
Mean
Difference
(I-J)
95%
CI
Mean
Difference
P-value
(I-J)
95%
CI
P-
value
-11.5,
5.49
1.000
-2.02
-6.17,
2.12
1.000
0.39
0.170,
0.605
0.001
-17.96,
-0.90
0.021
-6.25
-10.67,
-2.37
<0.001
1.12
0.905,
1.339
<0.001
-20.18,
-3.12
0.002
-8.57
-12.72,
-4.42
<0.001
1.31
1.092,
1.527
<0.001
-5.49,
11.56
1.000
2.02
-2.12,
6.17
1.000
-0.39
-0.605,
-0.170
0.001
-14.92,
2.13
0.284
-4.49
-8.64,
-0.34
0.026
0.73
0.517,
0.952
<0.001
-17.14,
-0.08
0.046
-6.54
-10.69,
-2.39
<0.001
0.92
0.705,
1.139
<0.001
0.90,
17.96
0.021
6.52
2.37,
10.67
<0.001
-1.12
-1.339,
-0.905
<0.001
-2.13,
14.92
0.284
4.49
0.34,
8.64
0.026
-0.73
-0.952,
-0.517
<0.001
-10.75,
6.31
1.000
-2.04
-6.19,
2.10
1.000
0.19
-030,
0.405
0.091
3.12,
20.18
0.002
8.57
4.42,
12.72
<0.001
-1.31
-1.527,
-1.092
<0.001
0.08,
17.14
0.046
6.54
2.39,
10.69
<0.001
-0.92
-1.139,
-0.705
<0.001
-6.31,
10.75
1.000
2.04
-2.10,
6.19
1.000
-0.19
-0.405,
0.30
0.091
Mode Mode
Mean
Difference
(I)
(J)
(I-J)
A
B
C
D
n
ta
:
I>
t
it
d>
t
ic
.
)
t
in
t
d
-3.03
-
9.43
-11.65
3.03
-
6.39
-
8.61
9.43
6.39
-2.22
11.65
8.61
2.22
Sy
go
lic
bloo
d
p
r
e
55
u
Fc
115
11D
115
120
115
110
105
A
Effects
of
Changes
in
Sodium
Concentration
123
TABLE
4.
The
mean
difference
systolic
and
diastolic
blood
pressure
and
intradialytic
hypotension
in
different
modes
in
dialyzed
patients
Systolic
Blood
Pressure
Diastolic
Blood
Pressure
Intradialytic
Hypotension
A:
dialysate
temperature
37°C,
dialysate
sodium
138
mmol/L;
B:
dialysate
temperature
35°C,
dialysate
sodium
138
mmol/L;
C:
dialysate
temperature
37
°C
with
sodium
150
mmol/L
in
first
hour
of
dialysis
and
decreased
to
138
mmol/L
in
the
last
hour
of
dialysis;
D:
dialysate
temperature
35
°C
with
sodium
150
mmol/L
in
first
hour
of
dialysis
and
decreased
to
138
mmol/L
in
the
last
hour
of
dialysis;
CI,
Confidence
Intervals.
..................
gr
vor...Mq
ar
es.
-do
Hades
cr
ireal
ment
k-
dialypte
temperature
37`C,
dialysate
ecidiurn
1.38
mmol/L,
8:
dialysate
temperatre
35X,dalysa
to
sodium
138
meriolft,
C:
dialysate
temperature
37t,diatysate
sodium
changed
from
150
r1101114A
te5
138
mmit,
0;
dialysate
temperature
38
6
C,
dialysate
sodium
changed
from
ma
mmovrt
to
138
rrio4/1
;
systolic
blood
pressure
18
minutes
before
dialysis;
2:
systolic
blood
pressure
at
the
first
hour
during
dialysis;
3;
systolic
blood
pressure
at
the
second
hour
during
dialysis;
4z
systolic
blood
pressure
at
the
third
hour
during
dialysis:
5:
systolic
blood
pressure
15
minutes
after
dialysis
Estimated
Marginal
Mean
of
Systolic
Blood
Pressure
FIG.
2.
Estimated
marginal
mean
of
systolic
blood
pressure.
[Color
figure
can
be
viewed
at
wileyonlinelibrary.com
]
group
(cold
dialysis,
sodium
concentration
3,
and
UF
profile
3)
was
lower
than
cold
dialysis
group,
as
well
as
in
group
treated
with
sodium
concentration
3
and
UF
profile
3.
Based
on
the
results
of
the
mentioned
study,
the
difference
was
significant
like
the
results
of
the
present
study
(11).
It
should
be
noted
that
the
mentioned
study
did
not
compare
the
above
methods
with
the
standard
dialysis
method.
The
primary
limitation
of
this
study
was
small
sam-
ple
size.
In
addition,
dietary
sodium
and
glucose
intake,
which
may
affect
the
osmolality
and
blood
pressure,
were
not
measured.
To
minimize
these
lim-
itations,
Williams'
design
and
crossover
sampling
was
used.
Moreover,
a
number
of
intradialytic
complica-
tions
such
as
weight
gain
and
muscle
cramps,
which
might
be
a
result
of
plasma
sodium
changes,
were
(0
2017
International
Society
for
Apheresis,
Japanese
Society
for
Apheresis,
and
Japanese
Society
for
Dialysis
Therapy
Ther
Apher
Dial,
Vol.
21,
No.
2,2017
124
H
Ebrahimi
et
al.
3
4
1!!
tw
10
75
70
65
Sc
SD
....................
41.1.
110.•
A
modes
of
Treatment
A:
dialysate
temperature
SrC,
dialysate
sodium
118
mmol/L,
13:
dralysate
temperature
SVC,
dialysate
sodium
13B
rurnolft,
C:
dialysate
temperature
37"C,
dialysate
sodiumchanged
from
150
mmol/L
to
138
rnmolit
r
ri!
dialysate
temperature
35`C,
dialysate
sodi
urn
changed
from
150mmol/L
to
133
mmolft
1:
diastolic
blood
pressure
15
minutes
before
dialysis:
2:
cliastcarc
blood
pressure
at
the
first
hour
during
dialysis;
3:
diastolic
blood
pressure
at
the
second
hour
during
dialysis;
4:
I:Neste:1hr
blood
pressure
at
the
third
hour
during
dialysis;
51
diastolic
blood
pressure
15
minutes
after
HG.
3.
Estimated
marginal
mean
of
diastolic
blood
pressure.
[Color
figure
can
be
viewed
at
wileyonlinelibrary.com
]
TABLE
5.
The
effect
of
different
independent
variables
on
systolic
and
diastolic
blood
pressure
and
intradialytic
hypotension
in
dialyzed
patients
in
a
Generalized
Estimating
Equation
model
Independent
Systolic
Blood
Pressure
Diastolic
Blood
Pressure
Intradialytic
Hypotension
Variables
Coefficient
95%
CI
P-value
Coefficient
95%
CI
P-value
Coefficient
95%
CI
P-value
Mode
4.19
2.20,
6.19
0.001
3.03
2.05,
4.01
<0.001
-1.81
-2.04,
-1.58
<0.001
Group
0.69
-2.22,
3.61
0.642
0.10
-1.32,
1.53
0.88
-0.01
-0.33,
0.31
0.937
Carry
Over
Effect
0.23
-0.87,
1.33
0.681
0.04
-0.49,
0.58
0.87
.0.01
-0.12,
0.13
0.934
Sex
-2.79
-7.24,
1.64
0.217
-0.97
-3.15,
1.20
0.38
0.64
-0.68,
1.35
0.076
Age
-0.17
-.32,
-.024
0.022
-0.08
-0.15,
-0.01
0.034
-0.02
-0.04,
-0.01
0.174
Constant
120.31
103.55,
137.08
<0.001
68.08
59.85,
76.31
<0.001
11.69
10.19,
13.19
<0.001
CI,
Confidence
intervals;
Carry
over
effect,
Carry
over
effect
refers
to
the
remaining
bias
due
to
previous
exposure
in
the
course
of
further
study
for
another
exposure.
No
significant
in
carry
over
effect
means
that
the
previous
intervention
had
no
effect
on
results
(systolic
and
diastolic
blood
pressure
and
intradialytic
hypotension)
in
the
next
exposure.
Constant
is
the
intercept
in
the
GEE
regression
model.
not
assessed.
Also
some
variables
such
as
severity
of
anemia,
hypoalbuminemia,
and
cardiac
dysfunction
might
play
a
role
in
reducing
blood
pressure
during
the
dialysis
session.
In
order
to
reach
an
equal
distribution
of
the
effective
variables
on
patient's
blood
pressure,
we
used
randomization.
Meanwhile,
we
considered
all
patients
in
both
control
and
inter-
vention
groups
to
be
in
the
same
condition
using
the
Cross-Over
method.
As
20
patients
were
discon-
nected
from
the
dialysis
machines
at
the
end
of
the
fourth
hour,
we
could
not
measure
their
blood
pressure.
Therefore,
after
the
end
of
dialysis,
blood
pressure
was
measured.
In
this
study
we
did
not
measure
the
time-course
of
serum
sodium
concentra-
tion.
Because
the
acute
change
in
serum
sodium
concentration
induces
central
pontine
myelitis,
we
encourage
readers
to
pay
attention
to
this.
The
major
strength
of
this
study
was
applying
Williams'
design
and
crossover
sampling.
Another
strong
point
of
this
study
was
the
use
of
advanced
statistical
analysis
methods,
particularly
the
use
of
GEE
model.
Litera-
ture
review
indicated
that
the
majority
of
studies
performed
in
this
field
were
cross-sectional,
and
the
effects
of
other
variables
were
not
considered
in
clinical
trial
studies.
According
to
the
results
of
this
study,
the
gradual
reduction
of
sodium
was
associated
with
lower
fluctu-
ations
in
blood
pressure.
Hence,
the
nursing
staff
are
recommended
to
use
gradual
reduction
of
sodium
(using
a
sodium
concentration
of
150
mmol/L
in
the
©
2017
International
Society
for
Apheresis,
Ther
Apher
Dial,
Vol.
21,
No.
2,
2017
Japanese
Society
for
Apheresis,
and
Japanese
Society
for
Dialysis
Therapy
Effects
of
Changes
in
Sodium
Concentration
125
first
hour
of
dialysis
and
then
lowering
it
to
138
mmol/L
in
the
last
hour
of
dialysis)
in
order
to
improve
the
quality
of
dialysis
and
prevent
hypoten-
sion
and
its
subsequent
complications,
particularly
in
intradialytic
hypotension
patients.
Acknowledgments:
This
study
was
extracted
from
a
nursing
master's
thesis.
The
authors
give
their
gratitude
to
the
patients
who
participated
in
this
study
and
authorities
of
the
hemodialysis
ward
at
Imam
Hossein
Hospital
in
Shahroud,
for
their
cooperation.
We
also
appreciate
the
research
deputy
of
Shahroud
University
of
Medical
Sciences
and
the
school
of
nursing
of
Islamic
Azad
University
for
their
cooperation
and
guidance.
Conflicts
of
Interest:
All
authors
declare
that
they
have
no
conflict
of
interest.
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2017
International
Society
for
Apheresis,
Japanese
Society
for
Apheresis,
and
Japanese
Society
for
Dialysis
Therapy
Ther
Apher
Dial,
Vol.
21,
No.
2,
2017