Comparisson of the Efficacy of Ringer's Lactate Serum as a Base Solution in Modified Del Nido Cardioplegia with Standard Del Nido Cardioplegia on Myocardial Damage Markers and Clinical Outcomes in Patients Undergoing Coronary Artery Bypass Graft

Comparisson of the Efficacy of Ringer's Lactate Serum as a Base Solution in Modified Del Nido Cardioplegia with Standard Del Nido Cardioplegia on Myocardial Damage Markers and Clinical Outcomes in Patients Undergoing Coronary Artery Bypass Graft

Randomized, single-blinded controlled trial, with parallel groups (allocation ratio 1:1).

This study is performed on patients who are candidates for coronary artery bypass surgery in Imam Hossein hospital (Tehran, Iran) in 1401. Eligible patients are divided into two groups (A and B) using a table of random numbers. In groups A and B, Ringer's lactate and plasmalite A solution are used for cardioplegia, respectively. Then, the markers of myocardial damage and the clinical outcomes of patients after surgery and at the admission to the intensive care unit are evaluated. In this single-blinded study, the patients are unaware of the allocation of individuals to the groups.

Inclusion criteria are: Candidate patients for coronary artery bypass graft, Candidate patients for 3 to 4 vascular grafts, Age between 18 and 75 years, Written informed consent to participate in the study, An ejection fraction higher than 35% before surgery, and Lack of multi-organ failure before surgery. Exclusion criteria are: Re-operation and Proven infection or inflammation within the last month

In this study, Ringer's lactate solution is used to cardioplegia in group A (modified Del Nino). Also, in group B, plasmalit A solution is used to cardioplegia (Del Nino standard). Cardioplegic solution is a solution that is used to protect the myocardium during surgery and during the period when the heart is deprived of blood circulation.

Clinical outcomes; Myocardial damage markers

The randomization method is a simple randomization that is done in the form of individual random units. The tool used to do this is a random numbers table. The method of constructing a random sequence is that first the researcher selects one of the numbers with his eyes closed and then moves in the right direction. Odd numbers are considered for intervention and even numbers are for control. Random concealment is also performed using sequentially numbered sealed opaque envelopes (SNOSE).

In this single-blinded study, patients who are candidates for coronary artery bypass grafting are blind to the group assignment. Others, including treating physician, methodologist, statistics specialist, nurses, authors of manuscript, and study designers, will be aware of the classification of patients into the two groups.