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IRCT20130304012695N17 IRCT 2023-05-13 Tehran University of Medical Sciences The use of testosterone in brain dead patients who are candidates for organ donation in order to maintain and stabilize blood pressure The effects of testosterone injection in maintaining the stability of blood pressure and hemodynamic parameters of brain dead patients who are candidates for organ donation 2023-05-22 anticipated 80 Complete https://irct.ir/trial/68393 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the randomization of patients who meet the inclusion criteria, the method of four blocks including intervention and control groups will be used.The preparation of randomization sequences will be done using the Random Generator software and the created sequences will be given to a trained staff member of the intensive care of unit who is not a member of the research group.The researchers of this study will not be aware of the existing sequences and arrangement of the blocks.After the patient enters the operating room, the trained person removes the first sequence from the special box of this study and according to the predetermined protocol, if it is T, it will be transferred to the intervention group, and if it is C, it will be transferred to the control group, Blinding description: In this study, patients do not know their group. Eligible participants to receive testosterone (group T) or placebo (group C) are determined according to a computerized randomization program.These drugs are prepared in syringes and the same volume and are identified with the patient's name and hospital registration number, and in the special care department, these drugs are given to the nurse caring for the patient who is blind to the assigned groups for injection.Another researcher, who is blinded to the assigned groups, will evaluate the hemodynamic status of the patient. 2-3 brain dead. Intervention 1: Intervention group: 100 mg of testosterone enanthate drug (manufactured by Caspian Tamin Company) was prepared by nurse of the intensive care department according to the grouping of the patient, and after taking a blood sample from the patient, it was injected into the deltoid muscle, the primary variables of the study were recorded and the care routin continues to maintain the patient's hemodynamics, and 8 hours after injection, primary variables will be re-evaluated. Intervention 2: Control group:The placebo drug that is the same volume as the intervention drug (manufactured by Caspian Tamin Company) was prepared by nurse of the intensive care department according to the grouping of the patient, and after taking a blood sample from the patient, it was injected into the deltoid muscle, the primary variables of the study were recorded and the care routin continues to maintain the patient's hemodynamics, and 8 hours after injection, primary variables will be re-evaluated. Yes - There is a plan to make this available What will be shared: Main study outcome data When: Six months after the end of the study To whom: University researchers Conditions: Share experiences to increase the knowledge Where to obtain: khajavim@tums.ac.ir -Dr.khajavi How to obtain: The request will be made by email and the answer will be given within two months Comments:
public Mohammad Reza Khajavi
Sina hospital Hassan Abad Sq, Imam khomeni St,
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 KHAGAVIM@TUMS.AC.IR Tehran University of Medical Sciences scientific Mohammad Reza Khajavi
Sina hospital Hassan Abad Sq, Imam khomeni St,
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 khajavim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Brain dead patients aged 18-60 years are candidates for organ donation 18 years 60 years Both Patients who have high blood pressure and do not need inotropes Hemodynamically unstable patients who will undergo organ donation surgery in less than 6 hours G96.8 Other specified disorders of central nervous system Treatment - Drugs Treatment - Drugs Intervention group: 100 mg of testosterone enanthate drug (manufactured by Caspian Tamin Company) was prepared by nurse of the intensive care department according to the grouping of the patient, and after taking a blood sample from the patient, it was injected into the deltoid muscle, the primary variables of the study were recorded and the care routin continues to maintain the patient's hemodynamics, and 8 hours after injection, primary variables will be re-evaluated. Control group:The placebo drug that is the same volume as the intervention drug (manufactured by Caspian Tamin Company) was prepared by nurse of the intensive care department according to the grouping of the patient, and after taking a blood sample from the patient, it was injected into the deltoid muscle, the primary variables of the study were recorded and the care routin continues to maintain the patient's hemodynamics, and 8 hours after injection, primary variables will be re-evaluated. Dosage of noradrenaline. Timepoint: At the beginning of the patient's entry into the study and 8 hours after drug injection. Method of measurement: milliliters per hour. Peripheral vascular resistance. Timepoint: At the beginning of the patient's entry into the study and 8 hours after drug injection. Method of measurement: By Ultrasonic Cardiac Output Monitor. Cardiac output. Timepoint: At the beginning of the patient's entry into the study and 8 hours after drug injection. Method of measurement: By Ultrasonic Cardiac Output Monitor. Cardiac Index. Timepoint: At the beginning of the patient's entry into the study and 8 hours after drug injection. Method of measurement: By Ultrasonic Cardiac Output Monitor. Tehran University of Medical Sciences Approved 2023-05-09 Research Ethics Committees of Sina Hospital Sina Hospital, Imam Khomeini st. Tehran Tehran Iran (Islamic Republic of)