GLP-1 and Hyperoxia for Organ Protection in Heart Surgery
Summary
Patients undergoing open heart surgery are at risk of suffering damage to the heart, brain and kidneys. This study is designed as a 2-by-2 randomized clinical trial with the purpose of investigating the organ protective effects of the glucagon-like-peptide-1 (GLP-1) agonist Exenatide versus placebo and restrictive versus liberal oxygenation during weaning from cardio-pulmonary bypass.
Timeline
- Start
- 2016-02
- Primary completion
- 2024-09
- Completion
- 2024-09
Outcome
Missed primary endpoint
paper 167/695 (24%) participants in the restrictive oxygenation group and 168/694 (24%) participants in the liberal oxygenation group met the primary endpoint PMID 40975689 ↗
paper hazard ratio, 1.01 [95% confidence interval, 0.8-1.3]; P=0.92 PMID 40975689 ↗
paper Exenatide during cardiopulmonary bypass and weaning thereof did not significantly reduce the incidence of death, stroke, renal failure, or new/worsening heart failure PMID 40265262 ↗
Publications
- Wiberg S, Moller CH, Kjaergaard J, Mikkelsen AD, Sorensen HM, Kunkel JB, Olsen PS, Hofsten DE, Ravn J, Ravn H, Boesgaard S, Hassager C, Kober L, Nilsson JC. Restrictive versus liberal oxygenation in patients undergoing cardiopulmonary bypass-assisted heart surgery: a randomised controlled trial. Br J Anaesth. 2025 Dec;135(6):1618-1625. doi: 10.1016/j.bja.2025.08.005. Epub 2025 Sep 19.
- Kjaergaard J, Moller CH, Wiberg S, Mikkelsen AD, Moller-Sorensen H, Ravn HB, Ravn J, Olsen PS, Hofsten DE, Boesgaard S, Kober L, Nilsson JC, Hassager C. Efficacy of the Glucagon-Like Peptide-1 Agonist Exenatide in Patients Undergoing CABG or Aortic Valve Replacement: A Randomized Double-Blind Clinical Trial. Circ Cardiovasc Interv. 2025 May;18(5):e014961. doi: 10.1161/CIRCINTERVENTIONS.124.014961. Epub 2025 Apr 23.
- Wiberg S, Kjaergaard J, Mogelvang R, Moller CH, Kandler K, Ravn H, Hassager C, Kober L, Nilsson JC. Efficacy of a glucagon-like peptide-1 agonist and restrictive versus liberal oxygen supply in patients undergoing coronary artery bypass grafting or aortic valve replacement: study protocol for a 2-by-2 factorial designed, randomised clinical trial. BMJ Open. 2021 Nov 5;11(11):e052340. doi: 10.1136/bmjopen-2021-052340.