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IRCT20211225053519N1 IRCT 2022-01-03 Iran University of Medical Sciences ٍEffects of adenosine in controlled reperfusion after heart valvular surgery Evaluation the effects of controlled aortic root reperfusion with and without adenosine on clinical outcome in patients undergoing heart valve surgery 2022-02-04 anticipated 60 Complete https://irct.ir/trial/60966 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the block randomization method. Blocking is usually used to balance the number of samples assigned to each study group. The size of all the blocks in this study is equal, and we will have a 4-person block size (two interventions and two controls). Random allocation software is also used as the randomization tool. The allocation concealment will be used for hiding so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequences, each of the random sequences created is recorded on a card, and the cards are placed in the envelopes, respectively. To maintain a random series, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order, and the assigned group of the participant is revealed, Blinding description: Each group will have a specific code and patients, outcome assessor, and data analyzer will not be informed of the intervention. 3 Surgery of the valvular heart disease. Intervention 1: Intervention group: In the intervention group and before off-pumping, warmblood with adenosine will be administered in a dose of 150 micrograms/kg (maximum dose: 12 milligrams), during 5-25 minutes (based on the return of cardiac contraction), in the volume of 200-250cc per minute, with the pressure of 30-50mm Hg by the roller pump through the cardioplegic line. Intervention 2: Control group: In the control group and before off-pumping, warmblood without adenosine will be administered during 5-25 minutes (based on the return of cardiac contraction), in the volume of 200-250cc per minute, with the pressure of 30-50mm Hg by the roller pump through the cardioplegic line. Yes - There is a plan to make this available What will be shared: All Deidentified Individual Participant Data Set will be available after the end of the study When: 6 month after publishing the results To whom: Researchers who work in academic institute Conditions: Data is given to the researchers just for assessment and not for interfering Where to obtain: Through email: Me_service22@yahoo.com How to obtain: The data will given to researchers after assessing the eligibility through email Comments:
public Mohammad Amin Shahrbaf
Shahid Rajaei Research & Training Hospital, Next to Mellat Park, Vali-Asr Ave, Tehran, IRAN.
Tehran Iran (Islamic Republic of) 199697751 +98 21 23921 Aminshahrbaf41@gmail.com Iran University of Medical Sciences scientific Mohammad Amin Shahrbaf
Shahid Rajaei Research & Training Hospital, Next to Mellat Park, Vali-Asr Ave, Tehran, IRAN.
Tehran Iran (Islamic Republic of) 199697751 +98 21 23921 Aminshahrbaf41@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Elective (not emergency) valvular surgery Cardiopulmonary bypass, and need for aortic cross-clamp and cardioplegia during operation Ejection fraction more than 35% before the surgery Negative history for previous cardiac surgery Lack of ventricular hypertrophy based on the preoperative echocardiography Lack of Inotropic consumption before the operation Lack of pacemakers or implantable cardioverter-defibrillator Pulmonary artery pressure less than 65mm Hg Filling the informed consent form 18 years 65 years Both Returning to cardiopulmonary bypass during the operation Need for intra aortic balloon pump Need for mechanical heart support I05-I09, Q Chronic rheumatic heart diseases, Congenital malformations of the circulatory system Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group and before off-pumping, warmblood with adenosine will be administered in a dose of 150 micrograms/kg (maximum dose: 12 milligrams), during 5-25 minutes (based on the return of cardiac contraction), in the volume of 200-250cc per minute, with the pressure of 30-50mm Hg by the roller pump through the cardioplegic line. Control group: In the control group and before off-pumping, warmblood without adenosine will be administered during 5-25 minutes (based on the return of cardiac contraction), in the volume of 200-250cc per minute, with the pressure of 30-50mm Hg by the roller pump through the cardioplegic line. Need for inotropic or anti arrhythmic drugs. Timepoint: Immediately after the surgery, during ICU stay. Method of measurement: Assessing receive/not receiving inotropic or anti arrhythmic drugs based on the medical record during the hospitalization. Use of defibrillator. Timepoint: Immediately after the surgery. Method of measurement: Assessing the need for defibrillator based on the medical record during the hospitalization. Type and time of the reentry rhythm. Timepoint: Immediately after the surgery. Method of measurement: Cardiac monitoring. Cardiopulmonary Bypass Time. Timepoint: During the operation. Method of measurement: Time of the cardiopulmonary bypass in minutes. Aortic Cross Clamp Time. Timepoint: During the operation. Method of measurement: Time of the aortic cross clamp in minutes. ICU stay. Timepoint: After the operation. Method of measurement: ICU stay based on days. Mechanical Ventilation time. Timepoint: During the operation. Method of measurement: Mechanical ventilation time in minute. Troponin laboratory assessment. Timepoint: After the operation. Method of measurement: Biochemical assessment. CPK assessment. Timepoint: After the operation. Method of measurement: Biochemical analysis. Renal function assessment. Timepoint: After the operation. Method of measurement: Biochemical Assessment. Liver function assessment. Timepoint: After the operation. Method of measurement: Biochemical assessment. Iran University of Medical Sciences Approved 2020-06-27 Research Ethics Committees of Rajaie Cardiovascular Medical and Research Center Shahid Rajaei Cardiovascular Center, Next to Mellat Park, Vali-Asr Ave, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)