Andre Lamy, Glenn M Chertow, Michael Jessen, Alonso Collar, Craig D Brown, Charles A Mack, Mohamed Marzouk, Vincent Scavo, T Benton Washburn, David Savage, Julian Smith, Jayme Bennetts, Roland Assi, Christian Shults, Arman Arghami, Javed Butler, P J Devereaux, Richard Zager, Chao Wang, Steve Snapinn, Austin Browne, Jeannette Rodriguez, Stacey Ruiz, Bhupinder Singh
BACKGROUND: RBT-1 is a combination drug of stannic protoporfin (SnPP) and iron sucrose (FeS) that elicits a preconditioning response through activation of antioxidant, anti-inflammatory, and iron-scavenging pathways, as measured by heme oxygenase-1 (HO-1), interleukin-10 (IL-10), and ferritin, respectively. Our primary aim was to determine whether RBT-1 administered before surgery would safely and effectively elicit a preconditioning response in patients undergoing cardiac surgery. METHODS: This phase 2, double-blind, randomised, placebo-controlled, parallel-group, adaptive trial, conducted in 19 centres across the USA, Canada, and Australia, enrolled patients scheduled to undergo non-emergent coronary artery bypass graft (CABG) and/or heart valve surgery with cardiopulmonary bypass...
February 2024: EClinicalMedicine