962156
Last Update Posted: 2012-07-10
Recruiting has ended
All Genders accepted | 18 Years + |
804 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Scandinavian Starch for Severe Sepsis/Septic Shock Trial
* 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.
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.
Eligibility
Relevant conditions:
Severe Sepsis
Septic Shock
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov