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IRCT20191024045227N1 IRCT 2020-04-21 Iran University of Medical Sciences Myocardial protection in cardiac surgery Comparison the myocardial protection effect of modified Buck Berg Cardioplegia with modified Del Nido in adult patients under Mitral valve surgery 2018-04-21 anticipated 74 Complete https://irct.ir/trial/46820 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was performed by Random Allocation Software. Samples were divided into two groups according to Balanced Block Randomization ( Blood and Del Nido cardioplegia). Patients were randomly assigned to either Blood or Del Nido Cardioplegia according to the order of inclusion and selection, and cardioplegia was injected according to the order of each group, Blinding description: Due to the nature of the intervention and the difference in blood and cardioplegia proportions in the two types of blood (Buck Berg) and Del Nidoo cardioplegic solutions, it was not possible to blind the study to the perfusionist and surgeon. According to the definitions given for the type of cardioplegia solution used in the two groups of patients, it was noted that in Blood cardioplegia the proportion of blood to the cardioplegia solution is 4 to 1 (four times more blood is injected per dose) than in the Dil Nido solution. Conversely, this value is 1 to 4 (one quarter of blood solution is added per injection). This difference in the proportion of blood and cardioplegia and the difference in the interval required for repeated infusion of the solution reveals it to the perfusionist and surgeon.But other members of the ICU surgical team and carers did not know the type of cardioplegia used. (two sided blind).to 1 (four times more blood is injected per dose) than in the Dil Nido solution. Conversely, this value is 1 to 4 (one quarter of blood solution is added per injection). This difference in the proportion of blood and cardioplegia and the difference in the interval required for repeated infusion of the solution reveals it to the perfusionist and surgeon.But other members of the ICU surgical team and carers did not know the type of cardioplegia used. (two sided blind). 3 Cardiopulmonary bypass. Intervention 1: Intervention group: Intervention group: In the intervention group, the patient’s heart was stopped for cardiac surgery procedure with Dell Nido cardioplegia solution. In the treatment of cardiovascular disease surgical interventions are sometimes required. In order to enter the heart cavity and perform valve surgery, the heart needs to be stopped and free of blood. To do this, the patient is placed on an out-of-body circulatory system called cardiopulmonary bypass to replace the heart and lung function with an external system and protect other organs with it. In this way, blood is temporarily mimicked outside the patient's cardiovascular system, and the heart, lungs and sometimes kidneys are temporarily replaced by an alternative system. In patients undergoing bypass, a solution called cardioplegia is used to stop and make the heart bloodless. In this procedure, which is very complex and sensitive, it is necessary to consider many considerations so that after the end of the period of bloodlessness and stopping, the heart can begin to function with the proper energy and power. Certainly, patient health is directly linked to heart health and heart health as well as to the best ways to protect it against the effects of anemia and stoppage, re-circulation and resumption of activity. Intervention 2: Control group: In the control group, the patient’s heart was stopped for cardiac surgery procedure with Buck berg cardioplegia solution.In the treatment of cardiovascular disease surgical interventions are sometimes required. In order to enter the heart cavity and perform valve surgery, the heart needs to be stopped and free of blood. To do this, the patient is placed on an out-of-body circulatory system called cardiopulmonary bypass to replace the heart and lung function with an external system and protect other organs with it. In this way, blood is temporarily mimicked outside the patient's cardiovascular system, and the heart, lungs and sometimes kidneys are temporarily replaced by an alternative system. In patients undergoing bypass, a solution called cardioplegia is used to stop and make the heart bloodless. In this procedure, which is very complex and sensitive, it is necessary to consider many considerations so that after the end of the period of bloodlessness and stopping, the heart can begin to function with the proper energy and power. Certainly, patient health is directly linked to heart health and heart health as well as to the best ways to protect it against the effects of anemia and stoppage, re-circulation and resumption of activity. Yes - There is a plan to make this available What will be shared: All information about the study procedure and its implications are available. When: After 1399 To whom: Author and colleagues Conditions: For scientific reasons and By informing the author Where to obtain: Responsible author How to obtain: Acceptance of Author and colleagues Comments:
public Amene Ghanbari
Vali Asr Ave. خیابان ولیعصر
Tehran Iran (Islamic Republic of) 1995614331 009823922424 a.mghanbari@yahoo.com Iran University of Medical Sciences scientific Amene Ghanbari
Vali Asr Ave. ولیعصر
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 2424 a.mghanbari@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) • Patients undergoing elective (first) mitral valve replacement or repair surgery for the first time • Patients with cardiopulmonary bypass who need cardiac arrest (cross-clamp and cardioplegia injection) • Age 22 - 72 years • EF equal or more than 40% preoperative • CPB time more than 60 min and less than 120 min • Having elective surgical consent • pulmonary artery pressure less than or equal to 50 mmHg preoperatively 22 years 72 years Both • Previous Cardiac Surgery (Recurrent Patients) • EF less than 40% • pulmonary artery pressure more than 50 mmhg • Ventricular hypertrophy • Need for medication support (receiving inotropes before starting cardiac surgery) • Having a pacemaker or implantable cardioverter/defibrillator (ICD) I34.9 Nonrheumatic mitral valve disorder, unspecified Treatment - Surgery Treatment - Surgery Intervention group: Intervention group: In the intervention group, the patient’s heart was stopped for cardiac surgery procedure with Dell Nido cardioplegia solution. In the treatment of cardiovascular disease surgical interventions are sometimes required. In order to enter the heart cavity and perform valve surgery, the heart needs to be stopped and free of blood. To do this, the patient is placed on an out-of-body circulatory system called cardiopulmonary bypass to replace the heart and lung function with an external system and protect other organs with it. In this way, blood is temporarily mimicked outside the patient's cardiovascular system, and the heart, lungs and sometimes kidneys are temporarily replaced by an alternative system. In patients undergoing bypass, a solution called cardioplegia is used to stop and make the heart bloodless. In this procedure, which is very complex and sensitive, it is necessary to consider many considerations so that after the end of the period of bloodlessness and stopping, the heart can begin to function with the proper energy and power. Certainly, patient health is directly linked to heart health and heart health as well as to the best ways to protect it against the effects of anemia and stoppage, re-circulation and resumption of activity. Control group: In the control group, the patient’s heart was stopped for cardiac surgery procedure with Buck berg cardioplegia solution.In the treatment of cardiovascular disease surgical interventions are sometimes required. In order to enter the heart cavity and perform valve surgery, the heart needs to be stopped and free of blood. To do this, the patient is placed on an out-of-body circulatory system called cardiopulmonary bypass to replace the heart and lung function with an external system and protect other organs with it. In this way, blood is temporarily mimicked outside the patient's cardiovascular system, and the heart, lungs and sometimes kidneys are temporarily replaced by an alternative system. In patients undergoing bypass, a solution called cardioplegia is used to stop and make the heart bloodless. In this procedure, which is very complex and sensitive, it is necessary to consider many considerations so that after the end of the period of bloodlessness and stopping, the heart can begin to function with the proper energy and power. Certainly, patient health is directly linked to heart health and heart health as well as to the best ways to protect it against the effects of anemia and stoppage, re-circulation and resumption of activity. - Myocardial function. Timepoint: 1- pre operation 2 - post cardiopulmonary bypass 3 - post ICU 4 - post ICU. Method of measurement: 1- Echocardiography. - ICU stay. Timepoint: Time to transfer the patient from the ICU to the post-ICU care unit. Method of measurement: Day of ICU stay. Iran University of Medical Sciences Approved 2018-11-24 Ethics committee of Mashhad medical university Mashhad University of medical sciences, Vakil Abadblvd Mashhad Razavi Khorasan Iran (Islamic Republic of)