Effect of the Addition of Adenosine on Myocardial Protection During Cardiopulmonary Bypass

Summary

The goal of this clinical trial is to evaluate whether the addition of adenosine to standard cardioplegia improves myocardial protection in adult patients undergoing on-pump cardiac surgery. The study population includes adult patients of both sexes undergoing elective cardiac procedures requiring cardiopulmonary bypass and cardioplegic arrest. The main questions this trial aims to answer are: Does the addition of adenosine to cardioplegia affect myocardial protection as assessed by transesophageal echocardiography (TEE)? What is the effect of adenosine on biochemical markers of myocardial injury, such as postoperative high-sensitivity troponin levels? What is the effect of adenosine on perioperative hemodynamic support requirements, as quantified by the Vasoactive-Inotropic Score (VIS)? Researchers will compare patients receiving adenosine-supplemented cardioplegia with those receiving standard cardioplegia (placebo) to assess differences in echocardiographic indicators of myocardial protection, biomarker release, and need for vasoactive/inotropic support. Participants will: Receive either adenosine-supplemented cardioplegia (adenosine 1.2 mmol/L; 24 mg) or placebo according to randomization. Undergo standard perioperative monitoring during cardiac surgery. Undergo intraoperative transesophageal echocardiography (TEE) to evaluate myocardial protection by comparing pre- and post-cardiopulmonary bypass (CPB) measurements. Have postoperative laboratory testing for high-sensitivity troponin at baseline, 2h, 12h, and 24h after clamp release. Have hemodynamic support requirements recorded and VIS calculated at the end of surgery and at 12h and 24h postoperatively. Be followed for perioperative clinical outcomes including arrhythmias, need for cardioversion or mechanical circulatory support, ICU/hospital length of stay, myocardial infarction, and mortality.

Timeline

Start

2026-03-30

Primary completion

2027-07-01

Completion

2027-07-01

Publications

• Results Allen BS. Myocardial protection: a forgotten modality. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):263-270. doi: 10.1093/ejcts/ezz215.
• Results Singh A, Huang X, Dai L, Wyler D, Alfirevic A, Blackstone EH, Pettersson GB, Duncan AE. Right ventricular function is reduced during cardiac surgery independent of procedural characteristics, reoperative status, or pericardiotomy. J Thorac Cardiovasc Surg. 2020 Apr;159(4):1430-1438.e4. doi: 10.1016/j.jtcvs.2019.04.035. Epub 2019 Apr 26.
• Results Lira KB, Delvaux RS, Spadini FA, Hauschild LH, Ceron RO, Anschau F, Kopittke L, Rode J, Rey RAW, Wittke EI, Rombaldi AR, Cambruzzi E, Lopes ERC, Almeida AS. Myocardial protection: comparing histological effects of single-dose cardioplegic solutions-study protocol for a secondary analysis of the CARDIOPLEGIA trial. J Thorac Dis. 2024 Feb 29;16(2):1480-1487. doi: 10.21037/jtd-23-1442. Epub 2024 Feb 20.
• Results Almeida AS, Ceron RO, Anschau F, Kopittke L, Lira KB, Delvaux RS, Rode J, Rey RAW, Wittke EI, Rombaldi AR. Comparison between Custodiol, del Nido and modified del Nido in the myocardial protection - Cardioplegia Trial: a study protocol for a randomised, double-blind clinical trial. BMJ Open. 2021 Sep 6;11(9):e047942. doi: 10.1136/bmjopen-2020-047942.
• Results Ammar A, Mahmoud K, Elkersh A, Kasemy Z. A Randomized Controlled Trial of Intra-Aortic Adenosine Infusion Before Release of the Aortic Cross-Clamp During Coronary Artery Bypass Surgery. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2520-2527. doi: 10.1053/j.jvca.2017.10.041. Epub 2017 Dec 8.
• Results Abdelwahab AA, Sabry M, Elshora HA, Arafat AA. Effect of Fast Cardioplegic Arrest Induced by Adenosine on Cardiac Troponin Levels After Heart Valve Surgery. Heart Lung Circ. 2019 Nov;28(11):1714-1719. doi: 10.1016/j.hlc.2018.08.017. Epub 2018 Sep 12.
• Results Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.
• Results Mentzer RM Jr, Birjiniuk V, Khuri S, Lowe JE, Rahko PS, Weisel RD, Wellons HA, Barker ML, Lasley RD. Adenosine myocardial protection: preliminary results of a phase II clinical trial. Ann Surg. 1999 May;229(5):643-9; discussion 649-50. doi: 10.1097/00000658-199905000-00006.
• Results Wei M, Kuukasjarvi P, Laurikka J, Honkonen EL, Kaukinen S, Laine S, Tarkka M. Cardioprotective effect of adenosine pretreatment in coronary artery bypass grafting. Chest. 2001 Sep;120(3):860-5. doi: 10.1378/chest.120.3.860.
• Results Jakobsen O, Muller S, Aarsaether E, Steensrud T, Sorlie DG. Adenosine instead of supranormal potassium in cardioplegic solution improves cardioprotection. Eur J Cardiothorac Surg. 2007 Sep;32(3):493-500. doi: 10.1016/j.ejcts.2007.05.020. Epub 2007 Jul 5.
• Results Francica A, Tonelli F, Rossetti C, Tropea I, Luciani GB, Faggian G, Dobson GP, Onorati F. Cardioplegia between Evolution and Revolution: From Depolarized to Polarized Cardiac Arrest in Adult Cardiac Surgery. J Clin Med. 2021 Sep 29;10(19):4485. doi: 10.3390/jcm10194485.
• Results Vinten-Johansen J, Zhao ZQ, Corvera JS, Morris CD, Budde JM, Thourani VH, Guyton RA. Adenosine in myocardial protection in on-pump and off-pump cardiac surgery. Ann Thorac Surg. 2003 Feb;75(2):S691-9. doi: 10.1016/s0003-4975(02)04694-5.
• Results Jovanovic A, Lopez JR, Alekseev AE, Shen WK, Terzic A. Adenosine prevents K+-induced Ca2+ loading: insight into cardioprotection during cardioplegia. Ann Thorac Surg. 1998 Feb;65(2):586-91. doi: 10.1016/s0003-4975(97)01240-x.
• Results Dobson GP, Letson HL. Adenosine, lidocaine, and Mg2+ (ALM): From cardiac surgery to combat casualty care--Teaching old drugs new tricks. J Trauma Acute Care Surg. 2016 Jan;80(1):135-45. doi: 10.1097/TA.0000000000000881.

Drugs

Indications

No indication recorded.