Comparison of midodrine with L -carnitine in the treatment of intradialytic hypotension

Comparison of midodrine with L -carnitine in the treatment of intradialytic hypotension

Clinical trial with control group, with parallel group, single blind, randomized, on 30 patients. For randomization, block randomization are used. In order to blind the patients, they do not communicate with each other and do not know which group they belong to.

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 then randomized into two groups of 15 people. One group of patients was given oral L-carnitine at a dose of 1000 mg before each dialysis session 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.

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...

A group of patients is given oral L-carnitine 1000 mg 30-60 min before dialysis for one month. The second group is given midodrine 5 mg and half an hour before dialysis for one month.

Blood pressure changes between before and after dialysis timepoints

This update was made to correct inconsistencies in the original registry entry and to provide a more accurate and complete description of the prespecified and implemented study methodology. First, the allocation status was originally entered as “non-randomized,” although the protocol summary within the same original registry record explicitly described the study as a randomized clinical trial using block randomization. Therefore, this internal inconsistency was corrected, and the actual randomization procedure was clarified by specifying 1:1 allocation, blocked randomization with block sizes of 4, 6, and 10, and sequence generation using the Sealed Envelope tool. Second, an upper age limit of 65 years had been entered in the original registry record. This was corrected to “no upper age limit” to accurately reflect the prespecified eligibility criteria, while the minimum eligible age remained 18 years. Third, the description of the L-carnitine intervention was clarified. The original intervention field specified oral L-carnitine 1000 mg for one month but did not adequately specify its timing in relation to dialysis. The description was therefore completed to indicate administration of oral L-carnitine 1000 mg 30–60 minutes before each dialysis session for one month, consistent with the regimen implemented in the study. Finally, the description and assessment time points of the primary outcome were clarified.

Eligible participants were allocated to the midodrine or L-carnitine group in a 1:1 ratio. A blocked randomization sequence with block sizes of 4, 6, and 10 was generated using the Sealed Envelope online randomization tool.

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.

All data is potentially shareable after de-identifying individuals.

The access period starts 6 months after the results are published.

Public use

There is no obstacle to using the data by mentioning the source.

Shiraz university of medical sciences

The request for data should be made through the university website.