The effect of ultrafiltration profile on blood pressure control in patients undergoing hemodialysis
Design
cross over clinical trial with convenience sampling and single blind study on approximate 30 patients
Settings and conduct
Study in the field of hemodialysis will be performed in Shahid Beheshti hospital in Hamedan to investigate the effect of profiling on ultrafiltration. the type of profile that will apply to patients with intradialytic hypertension is interval with negative slope. Research sessions in each patient are 6 sessions, of which 3 sessions are with intervention and the other 3 sessions are without intervention. The study is single blind that patients after getting information about the research and accepting to attend the study they will not be informed of the routine or intervention of hemodialysis session.
Participants/Inclusion and exclusion criteria
Hemodialysis patients with intradialytic hypertension: Hemodialysis patients with normal blood pressure during dialysis and intradialytic hypotension.
Intervention groups
ََApply ultrafiltration profile with interval and negative slope
Main outcome variables
Increase or decrease in patients blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220206053954N1
Registration date:2022-03-18, 1400/12/27
Registration timing:prospective
Last update:2022-03-18, 1400/12/27
Update count:0
Registration date
2022-03-18, 1400/12/27
Registrant information
Name
Morteza Haghighi enayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 2379
Email address
morteza21.h@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-04-18, 1401/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ultrafiltration profile on blood pressure control in patients undergoing hemodialysis
Public title
The effect of ultrafiltration profile on blood pressure control in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
hemodialysis patients with intradialytic hypertension
Exclusion criteria:
Hemodialysis patients with cardiovascular disorders.
Hemodialysis patients whom is younger than 18 and older than 80 years.
Patients with no consentence.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
َAfter explaining to patients about the intervention and getting their permission, 6 sessions of hemodialysis will be performed by the researcher three sessions will be with intervention, and three sessions will be done routinely. patients will not be informed that in which sessions intervention will take place.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical science
Intradialytic hypertension among chronic hemodialysis patients
ICD-10 code
S37.0
ICD-10 code description
Injury of kidney
Primary outcomes
1
Description
The rate of increase in blood pressure
Timepoint
Before starting hemodialysis, 1 hour later, 2 hour later, 3 hour later and 15 minutes after the end of the session
Method of measurement
Analog blood pressure monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Apply interval profile with negative slope for ultrafiltration In three sessions of hemodialysis, which is applied from the beginning of hemodialysis until separation from the machine.blood pressure changes measured before starting hemodialysis, every hour during hemodialysis, and a quarter after completion.Na = 138 mE adjusted, pump speed 250 and solution temperature 36.5 ° C adjusted during hemodialysis
Category
Prevention
2
Description
Control group: Hemodialysis patients are hemodialyzed in the next three sessions without profile application in their ultrafiltration with Na = 138 mEq and pump speed of 250 and solution temperature 36.5 ° C adjusted during hemodialysis.