Comparison of midodrine with L -carnitine in the treatment of intradialytic hypotension
Design
Clinical trial with control group, with parallel group, single blind, randomized, on 30 patients. For randomization, blocks of four random places are used. In order to blind the patients, they do not communicate with each other and do not know which group they belong to.
Settings and conduct
Dialysis patients of Namazi and Shahid Faqihi Hospitals, who have been on dialysis for at least two months and who undergo dialysis at least twice a week, and who have a drop in blood pressure during dialysis in more than 50% of the dialysis sessions according to the variable definition of the plan, were selected and after Homogenization is divided into two groups of 15 people in terms of age and gender.
One group of patients was given oral L-carnitine at a dose of 20 mg/kg daily and the second group was given 5 mg midodrine half an hour before each dialysis for one month. At the end, the effect of the drug in two different groups on blood pressure drop during dialysis is investigated.
To blind the patients, they are not in contact with each other and do not know which group they belong to.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Dialysis patients of Namazi and Shahid Faqihi hospitals - At least two months have passed since they started dialysis - Dialysis at least twice a week - In more than 50% of dialysis sessions, intradialytic hypotension according to the variable definition of the plan.
Exit criteria: Intradialytic hypotension for other reasons such as sepsis, untreated active cancer, heart failure...
Intervention groups
A group of patients is given oral L-carnitine 1000 mg daily for one month. The second group is given midodrine 5 mg and half an hour before dialysis for one month.
Main outcome variables
Blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231223060507N1
Registration date:2024-01-15, 1402/10/25
Registration timing:registered_while_recruiting
Last update:2024-01-15, 1402/10/25
Update count:1
Registration date
2024-01-15, 1402/10/25
Registrant information
Name
Fatemeh Rohani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3226 1790
Email address
drfatemehrohani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of midodrine with L -carnitine in the treatment of intradialytic hypotension
Public title
Comparison of midodrine with L -carnitine in the treatment of intradialytic hypotension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dialysis patients of Namazi and Shahid Faqihi hospitals
At least two months have passed since they started dialysis
Dialyze at least twice a week
In more than 50% of dialysis sessions, intradialytic hypotension according to the variable definition of the plan
Exclusion criteria:
Intradialytic hypotension may be due to other reasons such as sepsis, untreated active cancer, heart failure...
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
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
The study is one-sided blind. Patients do not know how the drug is allocated and do not know which group they belong to.
The drug allocator does not know about the placement of people in two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Street , Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2023-12-26, 1402/10/05
Ethics committee reference number
IR.SUMS.MED.REC.1402.416
Health conditions studied
1
Description of health condition studied
End Stage Renal Diesease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Intradialytic hypotension
Timepoint
After the end of the one-month treatment period, blood pressure is measured in both groups and the increase in blood pressure compared to the time before the study is checked.
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of patient is given midodrine 5 mg a half hours before dialysis for one month
Category
Treatment - Drugs
2
Description
Intervention group: The second group of patients is given oral L-carnitine 1000 mg daily for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital and Shahid Faqihi Hospital
Full name of responsible person
Fatemeh Rohani
Street address
Internal Medicine Department , Namazi Hospital , Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
Drfatemehrohani@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Seventh floor, Shiraz University of Medical Sciences Central Building , Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Rohani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Group office , Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
drfatemehrohani@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Rohani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Group office , Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
drfatemehrohani@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Rohani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Group office , Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
drfatemehrohani@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Public use
Under which criteria data/document could be used
There is no obstacle to using the data by mentioning the source.
From where data/document is obtainable
Shiraz university of medical sciences
What processes are involved for a request to access data/document
The request for data should be made through the university website.