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IRCT20230425057989N1 IRCT 2023-05-07 Shahre-kord University of Medical Sciences Effect of oral L-carnitine on echocardiography of dialysis patients Evaluation of the effect of oral l-carnitine on echocardiography criteria in patients with pulmonary artery hypertension due to dialysis 2023-05-09 anticipated 40 Complete https://irct.ir/trial/69751 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To create a random sample, a simple randomization method using a table of random numbers will be used. In this method, the information of all dialysis patients of the studied dialysis centers is collected and their names are written in a list and each patient will be assigned a number in the order of writing. Then, using the table of random numbers (choosing the first number randomly, moving from left side to right in the table of random numbers and considering the last two digits of each random number) according to the sample size, the patients who will enter the study are selected. To determine the patient placement group (intervention or control) according to the selection order of the people who entered the study, the people whose selection order is odd number will be placed in the intervention group and other people will be in the control group, Blinding description: The type of blinding of the study is double-blind, and the patients and the statistical consultant are unaware of the type of treatment. Given that the packaging of the placebo pill is completely similar to the original drug, and the researcher and the patient are not aware of the contents of the package. And the labeling is done with a random code. 3 pulmonary hypertension. Intervention 1: Intervention group: First, echocardiography, 6-minute walk test (6MWT) and NYHA criteria are examined for patients. The results of 6MWT distance, pulse count and distance covered during 6 minutes and SpO2 with pulse oximetry will be measured at the end, one minute and 3 minutes after the completion of the 6MWT test. In NYHA criteria, patients are scored according to their statements during the medical interview or visible symptoms. In addition to routine treatment, patients receive L-carnitine 1000 mg every 12 hours for three months. Finally, after 3 months of receiving the drug, echocardiography, NYHA criteria and 6MWT will be repeated and data will be collected. Intervention 2: Control group: First, echocardiography, 6-minute walk test (6MWT) and NYHA criteria are examined for patients. The results of 6MWT distance, pulse count and distance covered during 6 minutes and SpO2 with pulse oximetry will be measured at the end, one minute and 3 minutes after the completion of the 6MWT test. In NYHA criteria, patients are scored according to their statements during the medical interview or visible symptoms. In addition to routine treatment, patients receive placebo every 12 hours for three months. Finally, after 3 months of receiving the placebo, echocardiography, NYHA criteria and 6MWT will be repeated and data will be collected. Yes - There is a plan to make this available What will be shared: To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published. When: The access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions Conditions: If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data. Where to obtain: In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address afiyeh.mirzaali@gmail.com or the contact number 0098911793259 How to obtain: To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most. Comments:
public Afiyeh Mirzaali
Kashani Street
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 afiyeh.mirzaali@gmail.com Shahre-kord University of Medical Sciences scientific Zahra Habibi
Kashani Street
Sharekord Iran (Islamic Republic of) 8816754633 0098383222116 dr_z_habibi@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) More than 13 years of age History of at least six months of hemodialysis Having a case in the dialysis department Performing dialysis 2 or 3 times a week for 3-4 hours each time Not having physical and mental disabilities The patient's dry weight remains constant 13 years no limit Both Suffering from chronic physical disorders such as heart, respiratory, and liver diseases Kidney transplant history Unwillingness to continue cooperation Death Travel Occurrence of unwanted drug side effects Not taking medicine for more than a week I27.2 Other secondary pulmonary hypertension Treatment - Drugs Placebo Intervention group: First, echocardiography, 6-minute walk test (6MWT) and NYHA criteria are examined for patients. The results of 6MWT distance, pulse count and distance covered during 6 minutes and SpO2 with pulse oximetry will be measured at the end, one minute and 3 minutes after the completion of the 6MWT test. In NYHA criteria, patients are scored according to their statements during the medical interview or visible symptoms. In addition to routine treatment, patients receive L-carnitine 1000 mg every 12 hours for three months. Finally, after 3 months of receiving the drug, echocardiography, NYHA criteria and 6MWT will be repeated and data will be collected. Control group: First, echocardiography, 6-minute walk test (6MWT) and NYHA criteria are examined for patients. The results of 6MWT distance, pulse count and distance covered during 6 minutes and SpO2 with pulse oximetry will be measured at the end, one minute and 3 minutes after the completion of the 6MWT test. In NYHA criteria, patients are scored according to their statements during the medical interview or visible symptoms. In addition to routine treatment, patients receive placebo every 12 hours for three months. Finally, after 3 months of receiving the placebo, echocardiography, NYHA criteria and 6MWT will be repeated and data will be collected. Pulmonary artery pressure. Timepoint: Before and after 3 months from the start of the intervention. Method of measurement: Echocardiography. Arterial oxygen saturation. Timepoint: Before and after 3 months from the start of the intervention. Method of measurement: Pulse oximetry. Number of times of hemodialysis per week. Timepoint: Before and after 3 months from the start of the intervention. Method of measurement: Number of times of hemodialysis per week. Right ventricular function. Timepoint: Before and after 3 months from the start of the intervention. Method of measurement: Echocardiography. Shortness of breath. Timepoint: Before and after 3 months from the start of the intervention. Method of measurement: NYHA (New York Heart Association Functional Classification). Shahre-kord University of Medical Sciences Approved 2021-10-18 Ethics committee of Shahrekord University of Medical Sciences Kashani street Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)