Scandinavian Starch for Severe Sepsis/Septic Shock Trial (6S)
- 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.
|Severe Sepsis Septic Shock||Drug: 6% Hydroxyethyl starch 130/0.4 Drug: Ringers acetate||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis|
- Mortality or dialysis-dependency [ Time Frame: 90 days ]
- Mortality [ Time Frame: 28 days ]
- Mortality [ Time Frame: 6 months ]
- Mortality [ Time Frame: 1 year ]
- Severity organ failure assessment score [ Time Frame: Day 5 ]Excluding Glascow coma score
- Days free of ventilation [ Time Frame: 90 days ]Among survivors
- Days free of dialysis [ Time Frame: 90 days ]Among survivors
- Serious adverse reactions [ Time Frame: Followed up until ICU discharge; consequently the time frame will vary among patients ]Severe bleeding or severe allergic reactions
- Need of dialysis/haemofiltration [ Time Frame: Within 90 days ]
- Need of ventilation [ Time Frame: Within 90 days ]
- Kidney failure [ Time Frame: Followed up until ICU discharge; consequently the time frame will vary among patients ]Severity organ failure assessment score > 2 in the renal component
- Hospital length of stay [ Time Frame: 90 days ]
- Coagulation analyses [ Time Frame: 5 days ]At selected hospitals whole-blood and biochemical coagulation analyses constitute additional secondary endpoints
- NGAL [ Time Frame: 5 days ]At selected trial sites will plasma and urinary NGAL be analysed at randomisation to assess the predictive value for dialyse and kidney failure
|Study Start Date:||December 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: HES 130/0.4
Drug: 6% Hydroxyethyl starch 130/0.4
Infusion for volume expansion in the ICU
Other Name: 6% Tetraspan
Active Comparator: Ringer acetate
Drug: Ringers acetate
Infusion for volume expansion in the ICU
Other Name: Ringerfundin / Sterofundin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962156
|Odense University Hospital|
|Dept of Intensive Care, Helsinki University Hospital|
|Dept. of Intensive Care, Kuopio University Hospital|
|Dept of Intensive Care, Tampere University Hospital|
|Dept. of Intensive Care, Landspitali|
|Haukeland University Hospital|
|Stavanger University Hospital|
|Intensive Care Unit, University Hospital of North Norway|
|St Olavs Hospital, Trondheim University Hospital|
|Principal Investigator:||Anders Perner, MD, PhD||ICU, Rigshospitalet, University of Copenhagen|
|Study Director:||Nicolai Haase, MD||Rigshospitalet, Denmark|