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Does volume substitution with HES 130/0.4 affect renal safety in abdominal aortic surgery?

Abdominal aortic surgery patients are at risk for renal dysfunction, notably if preoperatively the renal function is impaired. This sensitive patient population was chosen to prove that the recent hydroxyethyl starch (HES) 130/0.4 has no adverse renal effects as asserted for less metabolisable HES preparations.

After IRB approval and signed informed consent, 65 adult patients scheduled for abdominal aortic surgery were randomly allocated to receive either 6% HES 1300.4 (Voluven, n = 32) or 3% gelatin solution (Plasmion, n = 33) for perioperative volume substitution. The daily dose limitation for HES was 50 ml/kg body weight Baseline renal function was impaired in all patients (creatinine clearance (CrCl) <80 ml/min). The primary renal safety parameter was the peak increase in serum creatinine through day 6 after surgery. Both groups were compared for non-inferiority of HES (predefined non-inferiority range HES < gelatin + 17.68 mol/l or 0.2 mg/dl). Other renal safety parameters were minimum postoperative CrCl, incidence of oliguria (urine output <500 ml/day), and adverse events (AEs) related to the renal system until hospital discharge.

Baseline characteristics, surgical procedures, and the mean total infused colloid volumes were similar between both groups. Postoperatively, the mean peak increase in creatinine was slightly higher in gelatin patients. Non-inferiority of HES was statistically proven by means of the appropriate nonparametric one-sided 95% CI for the difference HES-gelatin (-∞, 11 μmol/l). The minimum postoperative CrCl was lower for gelatin (see Table 1, mean values ± SD). Oliguria occurred in a few patients only (three HES vs four gelatin patients). One patient of the gelatin group required dialysis treatment following a cascade of AEs related to surgical complications. Mortality in both groups was 6% (two deaths/ group). No drug-related unfavourable effects on renal function were found for volume substitution with HES 130/0.4 compared with gelatin in patients with mild to severe renal insufficiency undergoing infrarenal abdominal aortic surgery.

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Godet, G., Lehot, J., Janvier, G. et al. Does volume substitution with HES 130/0.4 affect renal safety in abdominal aortic surgery?. Crit Care 10 (Suppl 1), P173 (2006).

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