Prostaglandin E1: a new agent for the prevention of renal dysfunction in high risk patients caused by radiocontrast media? PGE1 Study Group

Abstract

Background: Acute renal failure following the administration of radiocontrast media (RCM) is a complication found especially in patients with impaired renal function. Within the limits of a pilot study, the objective was to (a) show the effectiveness and compatibility of prostaglandin E(1) (PGE(1)=Alprostadil) in preventing acute renal failure in patients with elevated levels of serum creatinine and (b) to identify the most appropriate PGE(1)-dose.

Methods: 130 patients with renal impairment (serum creatinine >/=1.5 mg/dl) were included in the study prior to intravascular RCM injection. The patients received one of three different doses of PGE(1) (10, 20, or 40 ng/kg bodyweight/min) or placebo (physiologic sodium chloride solution) intravenously over a time period of 6 h (beginning 1 h prior to RCM application). Serum creatinine was measured 12, 24, and 48 h post RCM-application and creatinine clearance was determined with two 12 h collection periods, as well as one 24 h collection within 48 h post RCM administration. Adverse events during PGE(1) administration were recorded.

Results: In the placebo group, the mean elevation of serum creatinine was markedly higher (0.72 mg/dl) 48 h after RCM administration compared with the three PGE(1) groups (0.3 mg/dl in the 10 ng/kg/min group, 0. 12 mg in the 20 ng/kg/min group, and 0.29 mg/dl in the 40 ng/kg/min group). No clinically relevant changes were seen regarding the creatinine clearance in the four groups examined.

Conclusions: Results from this pilot-study suggest that intravenous PGE(1) may be used efficaciously and safely to prevent RCM-induced renal dysfunction in patients with pre-existing impaired renal function.