Abstract

Background: In the last years some large trials were conducted in critically ill patients with severe sepsis which demonstrated a higher risk for acute kidney failure and death after the use of HES. These assumptions were confirmed by some meta-analyses. Subsequently, based on these results, in October 2013 the PRAC recommended suspending marketing authorizations for infusion solutions containing HES. After Re-evaluation the PRAC changed the recommendation and the use of HES is currently allowed except for critically ill patient as well as those suffering from sepsis or burns. But the uncertainness remains especially for the administration for surgical patients due to the lack of large trials in the perioperative setting. Aim: This study compares two time periods, one with the use of 6% HES 130/0.4 and one without the use the 6% HES 130/0.4 during surgeries at the Clinic of Anaesthsiology, Ludwig-Maximilians-University. The aim was to investigate differences caused by the different administration of the infusions and to assess side effects especially acute kidney failures und the risk of death. Methods: This controlled observational study was performed in a single-Centre university Hospital and compared two time periods including 12.089 patients. In the first period (1. August - 31. October 2012) the use of HES for fluid resuscitation during surgeries was allowed. In the second period (1. August - 31. October 2013) there was no administration of HES. For the assessment two groups were generated, one group with overall patients and one subgroup just for the assessment of the RIFLE-criteria. The primary outcome was the incidence of postoperative acute kidney failure within 90 days after surgery due to requiring RRT. Secondary outcomes were in-hospital mortality, blood loss, blood transfusions, fluid requirements, hemodynamic stability and the need for postoperative intensive care unit treatment. Results: The administration of HES 130/0.4 for fluid resuscitation was not associated with an increased frequency of postoperative acute kidney failure. The in-hospital mortality and the hemodynamic stability did not differ significantly between the groups. There was a significantly higher blood loss in the HES-group, however the need for blood transfusions, the fluid requirements and the need for intensive care unit treatment were significantly higher in the Non-HES group. Conclusions: Except of the higher intraoperative blood loss, there were no associations between intraoperative HES therapy and postoperative complications. There was no higher incidence of postoperative acute kidney failure and no higher risk of death after intraoperative administration of HES. Due to the limitations of the study, the results of this investigation are not valid for general recommendation for the use of HES 130/0.4 in the perioperative setting. For the evidence of the safety of HES 130/0.4, there must be conduct large, randomized trials with appropriate patients, a suitable control-group/control-fluid, a high power, a proper observation period and proper Follow-Up time in the future.