A double-blind, randomized, placebo-controlled trial of prostaglandin E 1 in liver transplantation

Abstract

A double-blind placebo-controlled trial of intravenous prostaglandin PGE 1 (40 Μg/h) was conducted in adult orthotopic liver transplant recipients. Infusion was started intraoperatively and continued for up to 21 days. Patients were followed up for 180 days postoperatively. Among 172 patients eligible for treatment in the study, 160 could be evaluated (78 PGE 1 ; 82 placebo). Patient and graft survival were similar (PGE 1 : 16 deaths, 9 retransplantations [7 survivors]; controls: 15 deaths, 6 retransplantations [3 survivors]). In patients with surviving grafts, however, PGE 1 administration resulted in a 23% shorter mean duration of hospitalization following transplantation (PGE 1 : 24.4 days; controls: 31.8 days; P = .02) and 40% shorter length of time postoperatively in the intensive care unit (PGE 1 : 8.2 days; controls 13.7 days; P = .05). Reduced needs for renal support ( P = .03) or surgical intervention other than retransplantation ( P = .02) were also noted with PGE 1 use. Further, PGE 1 administration resulted in a trend toward improved survival rates in patients with mild renal impairment (preoperative serum creatinine 1.5 mg percent or greater; P = .08). Neither the incidence of acute cellular rejection nor of primary nonfunction was significantly different in the two groups. Phlebitis was the only complication that was more common during PGE 1 administration, (PGE 1 : 9; controls: 4). These results suggest that PGE 1 use in hepatic allograft recipients reduces morbidity and may result in sizable cost reductions. (H EPATOLOGY 1995;21:366–372.)