NCT00962156

Scandinavian Starch for Severe Sepsis/Septic Shock Trial

Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 804 (actual)
• Sponsor: Anders Perner · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill. * High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis. * Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis. * HES 130/0.4 is largely unstudied in ICU patients. * This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis. * The trial will provide important data to all clinicians who resuscitate septic patients.

Detailed description

Fluid is the mainstay treatment in sepsis resuscitation, but the effects of different crystalloid and colloid solutions on outcome remain unknown. Previously, a high molecular weight hydroxyethyl starch, HES 200, was used, but this was found to cause acute kidney failure in patients with severe sepsis. As kidney failure is an independent risk factor for death in these patients, HES 200 is not used anymore. In stead a lower molecular weight starch, HES 130, has been developed. Presently, this is the preferred colloid in Scandinavian intensive care units (ICU), but the effects of HES 130 in ICU patients are currently unknown. The proposed Scandinavian multicentre study will be conducted to assess if HES 130 contributes to acute kidney failure in patients with severe sepsis. As HES 130 is widely used, the trial will provide important safety data to clinicians who resuscitate septic patients.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	6% Hydroxyethyl starch 130/0.4	Infusion for volume expansion in the ICU
DRUG	Ringers acetate	Infusion for volume expansion in the ICU

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-08-19
• Last updated: 2012-07-10

Locations

26 sites across 4 countries: Denmark, Finland, Iceland, Norway