Evaluation the effects of controlled aortic root reperfusion with and without adenosine on clinical outcome in patients undergoing heart valve surgery

Assessing the effect of aortic root controlled reperfusion with and without adenosine on postoperative outcome after valvular surgery

Randomized double-blind phase 3 clinical trial on 60 patients, with block randomization

This randomized double-blind clinical trial will conduct at Rajaei Cardiovascular center in 2022. The randomization will conduct by block randomization in a 1:1 allocation and patients will receive/not receive adenosine after off-pumping following valvular surgery.

Inclusion criteria: patients aged between 18-65, with no pacemakers, no ICD, and no need of inotropes, which undergone valvular heart surgery for the first time, and need a cardiopulmonary bypass, aortic cross-clamp, and cardioplegia, and EF more than 35%, lack of ventricular hypertrophy, pulmonary artery pressure less than 65 in their perioperative echocardiography. Exclusion criteria: the need for cardiopulmonary bypass after off-pumping, the need for Intra aortic balloon pump, the need for mechanical heart support.

In the intervention group: before off-pomping, 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. In the control group, warmblood without adenosine will be administered in the same protocol as the intervention group.

Need for inotropic drugs; Need for anti-arrhythmia drugs; Need for the defibrillator for off-pumping; Cross-clamp time

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.

Each group will have a specific code and patients, outcome assessor, and data analyzer will not be informed of the intervention.

All Deidentified Individual Participant Data Set will be available after the end of the study

6 month after publishing the results

Researchers who work in academic institute

Data is given to the researchers just for assessment and not for interfering

Through email: Me_service22@yahoo.com

The data will given to researchers after assessing the eligibility through email