Does volume substitution with HES 130/0.4 affect renal safety in abdominal aortic surgery?
© BioMed Central Ltd 2006
Published: 21 March 2006
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.
Peak increase in creatinine (μmol/l)
Minimum postoperative CrCl (ml/min)
26.3 ± 55.3
-47.0 to 222.0
61.1 ± 34.2
36.5 ± 103.3
-22.0 to 561.0
53.5 ± 25.2