Scandinavian Starch for Severe Sepsis/Septic Shock Trial
- Conditions
- Severe SepsisSeptic Shock
- Interventions
- Drug: 6% Hydroxyethyl starch 130/0.4
- Registration Number
- NCT00962156
- Lead Sponsor
- Anders Perner
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 804
All adult patients who
- Undergo resuscitation in the ICU
- AND fulfillment within the previous 24 hours of the criteria for severe sepsis (SCCM/ACCP)
- AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)
The following patients will not be evaluated for inclusion:
- Age < 18 years old
- Previously randomised in the 6S trial
- Allergy towards hydroxyethyl starch or malic acid
- Treatment with > 1000 ml's of any synthetic colloid within the last 24 hours prior to randomisation
- Any form of renal replacement therapy
- Acute burn injury > 10% body surface area
- Severe hyperkalaemia, p-K > 6 mM
- Liver or kidney transplantation during current hospital admission
- Intracranial bleeding within current hospitalisation
- Enrollment into another ICU trial of drugs with potential action on circulation, renal function or coagulation
- Withdrawal of active therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HES 130/0.4 6% Hydroxyethyl starch 130/0.4 Volume expansion Ringer acetate Ringers acetate Volume expansion
- Primary Outcome Measures
Name Time Method Mortality or dialysis-dependency 90 days
- Secondary Outcome Measures
Name Time Method Mortality 1 year Severity organ failure assessment score Day 5 Excluding Glascow coma score
Days free of ventilation 90 days Among survivors
Days free of dialysis 90 days Among survivors
Serious adverse reactions Followed up until ICU discharge; consequently the time frame will vary among patients Severe bleeding or severe allergic reactions
Need of dialysis/haemofiltration Within 90 days Need of ventilation Within 90 days Kidney failure 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 90 days Coagulation analyses 5 days At selected hospitals whole-blood and biochemical coagulation analyses constitute additional secondary endpoints
NGAL 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
Trial Locations
- Locations (26)
St Olavs Hospital, Trondheim University Hospital
🇳🇴Trondheim, Norway
Hjørring Hospital
🇩🇰Hjørring, Denmark
Holstebro Hospital
🇩🇰Holstebro, Denmark
Køge Hospital
🇩🇰Køge, Denmark
Vejle Hospital
🇩🇰Vejle, Denmark
Esbjerg Hospital
🇩🇰Esbjerg, Denmark
Hvidovre Hospital
🇩🇰Copenhagen, Denmark
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
Herlev Hospital
🇩🇰Copenhagen, Denmark
Glostrup Hospital
🇩🇰Copenhagen, Denmark
Herning Hospital
🇩🇰Herning, Denmark
Gentofte Hosptial
🇩🇰Copenhagen, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Hillerød Hospital
🇩🇰Hillerød, Denmark
Holbæk Hospital
🇩🇰Holbæk, Denmark
Næstved Hospital
🇩🇰Næstved, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Dept of Intensive Care, Helsinki University Hospital
🇫🇮Helsinki, Finland
Slagelse Hospital
🇩🇰Slagelse, Denmark
Sønderborg Hospital
🇩🇰Sønderborg, Denmark
Dept of Intensive Care, Tampere University Hospital
🇫🇮Tampere, Finland
Dept. of Intensive Care, Kuopio University Hospital
🇫🇮Kuopio, Finland
Stavanger University Hospital
🇳🇴Stavanger, Norway
Dept. of Intensive Care, Landspitali
🇮🇸Reykjavik, Iceland
Haukeland University Hospital
🇳🇴Bergen, Norway
Intensive Care Unit, University Hospital of North Norway
🇳🇴Tromsø, Norway