Phase I clinical trial of the feasibility and safety of direct peritoneal resuscitation in liver transplantation

Abstract

BackgroundDirect peritoneal resuscitation (DPR) is associated with improved outcomes in trauma. Animal models suggest DPR has favorable effects on the liver. We sought to evaluate its safety and assess for improved outcomes in liver transplantation (LT). MethodsLT patients with renal dysfunction and/or obesity were enrolled in a phase-I clinical trial. DPR lasted 8–24 ​h depending on postoperative disposition. Primary outcome was percent of patients completing DPR. Secondary outcomes evaluated complications. Controls with either obesity (control-1) or both risk factors (obesity ​+ ​renal dysfunction, control-2) were analyzed. ResultsFifteen patients were enrolled (seven with both criteria and eight with obesity alone). DPR was completed in 87 ​% of patients, with one meeting stopping criteria. Controls included 45 (control-1) and 24 (control-2) patients. Return to operating room, graft loss, and late infections were lower with DPR. ConclusionDPR appears to be safe in closed abdomens following LT, warranting a follow-up phase-II trial to assess efficacy.