Primary analysis of safety of 6% hydroxyethyl starch 130/0.4 for patients with shock during surgical perioperative period

Abstract

Objective To investigate the safety of fluid resuscitation with 6% hydroxyethyl starch(HES 130/0.4) for patients with shock during surgical perioperative period. Methods Clinical data of 279 patients with shock during surgical perioperative period in Department of Surgical Intensive Care Unit (SICU), the Third Affiliated Hospital of Sun Yat-sen University from March 2009 to December 2012 were analyzed retrospectively. The informed consents of all patients were obtained and the ethical committee approval was received. The patients were divided into HES group and albumin group according to whether they were resuscitated with 6% HES 130/0.4 within 48 hours of shock. There were 168 patients in HES group [109 males and 59 females, age of(64±17) years old], and 111 patients in albumin group[72 males and 39 females, age of (63±16) years old]. All patients received anti-shock therapy immediately after they were admitted in SICU. In HES group, 6% HES 130/0.4 was administered by intravenous infusion as the main colloid supplement, while albumin was administered in albumin group. The mortality, acute renal injury, new-onset function failure of other organs and adverse events of skin in two groups were observed. The comparison of measurement data between two groups was conducted using t test or rank sum test, and comparison of enumeration data was conducted using Chi-square test. Results The mortality was 17.9%(30/168) in HES group, and 17.1%(19/111) in albumin group. There was no significant difference between two groups(χ2=2.01, P>0.05). In HES group, 54.8%(92/168) of the patients were in renal injury risk period, 34.5%(58/168) of the patients were in renal injury period and 10.7%(18/168) of the patients were in renal failure period, while those were 55.0%(61/111), 35.1%(39/111) and 9.9%(11/111) respectively in albumin group. There was no significant difference (χ2=1.98, 1.82, 1.04; P>0.05). Renal-replacement therapy was used in 11.3% of the patients(19/168) in HES group, and that was 8.1%(9/111) accordingly in albumin group. There was no significant difference between two groups(χ2=20.23, P 0.05) . Compared with albumin group, the incidence of cardiovascular system failure significantly decreased in HES group[39.6% (44/111) vs. 36.3% (61/168) ; χ2=43.71, P 0.05). Conclusion Fluid resuscitation with 6% HES(130/0.4) for patients with shock during surgical perioperative period cannot reduce the mortality but can increase the probability of patients receiving the renal-replacement therapy. Key words: Hydroxyethyl starch (130/0.4); Shock, surgical; Safety; Acute renal injury; Liver failure, acute; Exanthema