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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

Published online by Cambridge University Press:  01 December 2008

G. Godet ,
J.-J. Lehot ,
G. Janvier ,
A. Steib ,
V. De Castro  and
P. Coriat
G. Godet*
Affiliation:
Université Pierre et Marie Curie, Assistance Publique-Hôpitaux de Paris, Centre Hospitalo-Universitaire Pitié-Salpêtrière, Department of Anesthesiology and Critical Care, Paris, France
J.-J. Lehot
Affiliation:
Hospices Civils de Lyon, Centre Hospitalo-Universitaire, Department of Anaesthesiology and Critical Care, Lyon, France
G. Janvier
Affiliation:
Centre Hospitalo-Universitaire de Bordeaux, Department of Anaesthesiology and Critical Care, Pessac, France
A. Steib
Affiliation:
Hôpitaux Universitaires de Strasbourg, Department of Anaesthesiology and Critical Care, Strasbourg, France
V. De Castro
Affiliation:
Université Pierre et Marie Curie, Assistance Publique-Hôpitaux de Paris, Centre Hospitalo-Universitaire Pitié-Salpêtrière, Department of Anesthesiology and Critical Care, Paris, France
P. Coriat
Affiliation:
Université Pierre et Marie Curie, Assistance Publique-Hôpitaux de Paris, Centre Hospitalo-Universitaire Pitié-Salpêtrière, Department of Anesthesiology and Critical Care, Paris, France
*
Correspondence to: Gilles Godet, Département d’Anesthésie Réanimation 2, CHU Rennes, Hôpital Pontchaillou, 2 rue Henri Le Guilloux, 35033-Rennes Cedex 9, France. E-mail: gilles.godet@chu-rennes.fr; Tel: +33 2 99 28 43 21; Fax: +33 2 99 28 25 50
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Summary

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®; n = 32) or 3% gelatin (Plasmion®; 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 parameter 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 μmol 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 [−∞, 11 μmol 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.

Keywords

CHRONIC RENAL INSUFFICIENCYSURGERY AORTICHYDROXYETHYL STARCHGELATINPOSTOPERATIVE ACUTE RENAL FAILURE
Type
Original Article
Information
European Journal of Anaesthesiology , Volume 25 , Issue 12 , December 2008 , pp. 986 - 994
Copyright
copyright © European Society of Anaesthesiology 2008

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