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IRCT20200825048515N67 IRCT 2023-05-18 Esfahan University of Medical Sciences The effect of two different doses of mannitol on the reduction of creatine phosphokinase in brain death patients Investigating the effect of two different doses of mannitol on reducing creatine phosphokinase (CPK) in brain death patients planned for organ donation 2023-06-21 anticipated 30 Complete https://irct.ir/trial/70128 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before starting the study, letter A is written on 15 sheets and letter B is written on 15 sheets, and each is placed in an envelope. Then, each eligible companion of patients who consented to participate in the study is asked to choose an envelope from among the envelopes. In this way, the patient will be randomly assigned to one of the two groups according to the envelope selected without the interference of the researcher, Blinding description: In order to comply with the conditions of double-blindness of the study, two doses of mannitol will be prepared by the nurse (without the knowledge of the researcher) daily and will be placed inside the bag and will be labeled A, B and will be given to the anesthetist (researcher) daily. Therefore, the researcher, the patient, the person recording the clinical and basic information of the patients, as well as the statistical analyst, will not be aware of the type of intervention. 2 Brain death. Intervention 1: First intervention group: In this group, 0.4 g/kg of mannitol along with 1 mEq of sodium bicarbonate per kilogram will be given in 20 minutes. Intervention 2: The second intervention group: In this group, 0.6 g/kg of mannitol along with 1 mEq of sodium bicarbonate per kilogram will be given in 20 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Parviz Kashefi
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Kashefi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Parviz Kashefi
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Kashefi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Confirmation of the patient's brain death Having the age of 16 to 55 years Confirmation of the patient's eligibility for kidney donation by the relevant team The presence of creatine phosphokinase greater than or equal to 5000 units per liter in the patient's initial test Consent of the patient's companions to perform the transplant and participate in the study 16 years 55 years Both Having a pacemaker Heart failure Sepsis G93.82 Brain death Treatment - Drugs Treatment - Drugs First intervention group: In this group, 0.4 g/kg of mannitol along with 1 mEq of sodium bicarbonate per kilogram will be given in 20 minutes. The second intervention group: In this group, 0.6 g/kg of mannitol along with 1 mEq of sodium bicarbonate per kilogram will be given in 20 minutes. Creatine phosphokinase. Timepoint: 8 hours after receiving each dose of mannitol. Method of measurement: Blood test. Creatinine. Timepoint: 8 hours after receiving each dose of mannitol. Method of measurement: Blood test. Sodium. Timepoint: 8 hours after receiving each dose of mannitol. Method of measurement: Blood test. Potassium. Timepoint: 8 hours after receiving each dose of mannitol. Method of measurement: Blood test. Blood pressure. Timepoint: 2 hours after receiving each dose of mannitol. Method of measurement: Sphygmomanometer. Heart beat. Timepoint: 2 hours after receiving each dose of mannitol. Method of measurement: Pulse oximeter. Isfahan University of Medical Sciences Approved 2019-07-28 School of Medicine- Isfahan University of Medical Science (Ethics committee in research) Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)