Safety of HES 130/0.4 (Voluven®) in patients with preoperative renal dysfunction undergoing abdominal aortic surgery: a prospective, randomized, controlled, parallel-group multicentre trial

Background and objective: Patients with impaired renal function are at risk of developing renal dysfunction after abdominal aortic surgery. This Study investigated the safety profile of a recent medium-molecular-weight hydroxyethyl starch (HES) preparation with a low molar substitution (HES 130/0.4) in this sensitive patient group, Methods: Sixty-five patients were randomly allocated to receive either 6% hydroxyethyl starch (Voluven (R) n = 32) or 3% gelatin (Plasmion (R); n = 33) for perioperative volume Substitution. At baseline, renal function was impaired in all study patients as indicated by a Measured creatinine clearance < 80 mL min(-1). The main renal safety para meter was the peak increase in serum creatinine up to day 6 after surgery. Results: Both treatment groups were compared for non-inferiority (pre-defined non-inferiority range hydroxyethyl starch < gelatin + 17.68 mu mol L-1 or 0.2 mg dL(-1)). Other renal safety parameters Included minimum postoperative creatinine clearance, incidence of oliguria and adverse events of the renal system. Baseline characteristics, Surgical procedures and the mean total infusion volume were comparable. Non-inferiority of hydroxyethyl starch vs. gelatin Could be shown by means of the appropriate non-parametric one-sided 95% CI for the difference hydroxyethyl starch - gelatin [-infinity, 11 mu mol L-1]. Oliguria was encountered in three patients of the hydroxyethyl starch and four of the gelatin treatment group. One patient receiving gelatin required dialysis secondary to surgical complications. Two patients of each treatment group died. Conclusion: As we found no drug-related adverse effects of hydroxyethyl starch on renal function, we conclude that the choice of the colloid had no impact on renal safety parameters and Outcome in patients with decreased renal function undergoing elective abdominal aortic Surgery.