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IRCT20100102002954N29 IRCT 2023-10-10 Shahroud University of Medical Sciences Comparison of the effect of sertraline and midodrine in improving blood pressure during hemodialysis A comparative study of the effect of sertraline and midodrine in improving blood pressure during hemodialysis in patients with chronic renal failure, a double-blind clinical trial 2023-10-23 anticipated 82 Complete https://irct.ir/trial/72551 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization method: use block. Random unit: individual. ŮŽ Randomization tool: An online randomization website. Sequence building: using block randomization method with block size of 4. Concealing method: using closed and opaque envelopes, Blinding description: In this study, clinical evaluator and analyzer are blinded. The allocation of patients into two groups A and B is done by a qualified nurse who has no aware of the actions performed in the two groups. Clinical examination and outcome evaluation will be record by a qualified nurse without any information about the type of intervention. 2-3 Hypotension of hemodialysis. Intervention 1: Intervention group: in the first intervention group, 50 mg of sertraline tablets half an hour before the start of dialysis will be administered for 4 weeks, and after a two-week wash out period, 5 mg of midodrine tablets will be administered half an hour before the start of dialysis for 4 weeks. Intervention 2: Intervention group: in the second intervention group, 5 mg of midodrine tablets half an hour before the start of dialysis will be administered for 4 weeks, and after a two-week wash out period, 50 mg of sertraline tablets will be administered half an hour before the start of dialysis for 4 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After completing the research and summarizing the results, it will be decided.
public Dr. Zahra Amirkhanloo
Imam Hossein Hospital., End Imam street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 zahra16.khanlu@gmail.com Shahroud University of Medical Sciences scientific Dr. Hoofer Rafiei
Imam Hossein hospital., End Imam street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 drrafiei@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) Patients undergoing permanent hemodialysis for at least 3 months, who have experienced hypotension during dialysis in at least 50% of hemodialysis cases; Performing at least 3 hours of hemodialysis at least 3 times a week; Stable vital signs; Having informed consent to participate in the research. 15 years 65 years Both The presence of severe and relatively severe coagulation problems; The presence of chronic lung and liver disease at the same time; The presence of any mental illness that takes SSRI drugs. I95.3 Hypotension of hemodialysis Treatment - Drugs Treatment - Drugs Intervention group: in the first intervention group, 50 mg of sertraline tablets half an hour before the start of dialysis will be administered for 4 weeks, and after a two-week wash out period, 5 mg of midodrine tablets will be administered half an hour before the start of dialysis for 4 weeks. Intervention group: in the second intervention group, 5 mg of midodrine tablets half an hour before the start of dialysis will be administered for 4 weeks, and after a two-week wash out period, 50 mg of sertraline tablets will be administered half an hour before the start of dialysis for 4 weeks. Systolic blood pressure value. Timepoint: Once every hour during hemodialysis. Method of measurement: Sphygmomanometer. Diastolic blood pressure value. Timepoint: Once every hour during hemodialysis. Method of measurement: Sphygmomanometer. Number of intradialytic hypotension episodes in each group. Timepoint: Dialysis even sessions. Method of measurement: Observation by educated and qualified nurse. Frequency of adverse drug reactions in each intervention group. Timepoint: From the start to the end of each medication intervention in each group. Method of measurement: Patient interview. Vice chancellor for research; Shahroud University medical and Sciences Approved 2023-08-30 Shahroud University of Medical Sciences Shahroud University of Medical Sciences; 7 Tir squer; Shahroud Shahroud Semnan Iran (Islamic Republic of)