A comparative study of the effect of proton pump inhibitor and ranitidine on serum magnesium level and blood pressure in chronic hemodialysis patients with hypotention
Detecting the effect of Proton pump inhibitors and Ranitidine on serum magnesium and blood pressure in chronic Hemodialysis patients with hypotension
Design
In this clinical trial, all hemodialysis patients in hemodialysis ward of Bou Ali hospital in Ardabil from October 1 st since at least 6 months ago (three times a week each session lenght three to four hours and developed hypotension during dialysis. (SBP <90) will be included in the study until completion.
Settings and conduct
Before starting the study, all packets containing medication and placebo were coded as A and B, respectively, to conduct a double blind study. Patients will be selected by census and will be randomly treated using sealed envelopes containing code A and code B. Patient or doctor and neurse delivering drug packages will not be aware of the type of medicine contained in the envelope. Initially, blood samples were taken from all patients and blood magnesium and blood pressure levels were recorded and then three months after completion of the study magnesium levels were checked and recorded. Then the intervention group received placebo Ranitidine (150 mg) and Pentoprazole (40 mg) and control group Placebo Pentoprazole (40 mg) and Ranitidine (150 mg) daily for three months. At the end of the study, sampling will be performed again to measure the level of repeated magnesium and the blood pressure .
Participants/Inclusion and exclusion criteria
ESRD patients with hypotension during dialysis
Intervention groups
group A Administered Tab Pantaprazol 40 mg and Placebo of Ranitidine 150 mg and for B group Tab Ranitidine 150 mg and Placebo of Pantaprazol 40 mg administered.
Main outcome variables
فشار خون -سطح سرمی منیزیم
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150808023559N19
Registration date:2019-11-05, 1398/08/14
Registration timing:registered_while_recruiting
Last update:2019-11-05, 1398/08/14
Update count:0
Registration date
2019-11-05, 1398/08/14
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of proton pump inhibitor and ranitidine on serum magnesium level and blood pressure in chronic hemodialysis patients with hypotention
Public title
A comparative study of the effect of proton pump inhibitor and ranitidine on serum magnesium level and blood pressure in chronic hemodialysis patients with hypotention
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
ESRD patients with hypotension during dialysis
Exclusion criteria:
Serum Magnesium below 2
Antihypertensive therapy
cancer
Severe Congestive Heart Failure
Age
To 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Dialysis patients suffering from hypotension during dialysis will be selected by census and will be randomly treated using packages containing code A and B (including placebo).
Blinding (investigator's opinion)
Double blinded
Blinding description
Packages containing the drug and placebo are given to patients in code A and B, and neither the physician nor the nurse delivering the drug will know the contents of the package.
Placebo
Used
Assignment
Parallel
Other design features
Sample size is about 50 people ,Case :25 control :25
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2019-08-18, 1398/05/27
Ethics committee reference number
IR.ARUMS.REC.1398.295
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Hypotension
Timepoint
Before starting the Hemodialysis and every 60 minutes during Hemodialysis
Method of measurement
Mercury barometer
Secondary outcomes
1
Description
Hypomagnesiumia
Timepoint
Before and after intervention
Method of measurement
Lab
Intervention groups
1
Description
Intervention group: To first this group Tab Pantaprazol with a dose of 40 mg and Placebo of Ranitidine with a dose of 150 mg administered
Category
Treatment - Drugs
2
Description
Control group: To control group Tab Ranitidine with a dose of 150 mg and Placebo of Pantaprazol with a dose of 40 mg administered
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Hospital
Full name of responsible person
Elham Saeedi
Street address
Varzesh Square
City
Ardabil
Province
Ardabil
Postal code
5613643197
Phone
+98 45 3325 2251
Email
bouali@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Dr.Susan Mohammadikebar
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
info@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ardabil University of Medical Sciences