Scandinavian Starch for Severe Sepsis/Septic Shock Trial (6S)
This study has been completed.
Sponsor:
Anders Perner
Collaborators:
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
B. Braun Melsungen AG
Information provided by (Responsible Party):
Anders Perner, Scandinavian Critical Care Trials Group
ClinicalTrials.gov Identifier:
NCT00962156
First received: August 18, 2009
Last updated: July 9, 2012
Last verified: July 2012
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Purpose
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Sepsis Septic Shock |
Drug: 6% Hydroxyethyl starch 130/0.4 Drug: Ringers acetate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Scandinavian Critical Care Trials Group:
Primary Outcome Measures:
- Mortality or dialysis-dependency [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Severity organ failure assessment score [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]Excluding Glascow coma score
- Days free of ventilation [ Time Frame: 90 days ] [ Designated as safety issue: No ]Among survivors
- Days free of dialysis [ Time Frame: 90 days ] [ Designated as safety issue: No ]Among survivors
- Serious adverse reactions [ Time Frame: Followed up until ICU discharge; consequently the time frame will vary among patients ] [ Designated as safety issue: Yes ]Severe bleeding or severe allergic reactions
- Need of dialysis/haemofiltration [ Time Frame: Within 90 days ] [ Designated as safety issue: No ]
- Need of ventilation [ Time Frame: Within 90 days ] [ Designated as safety issue: No ]
- Kidney failure [ Time Frame: Followed up until ICU discharge; consequently the time frame will vary among patients ] [ Designated as safety issue: No ]Severity organ failure assessment score > 2 in the renal component
- Hospital length of stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Coagulation analyses [ Time Frame: 5 days ] [ Designated as safety issue: No ]At selected hospitals whole-blood and biochemical coagulation analyses constitute additional secondary endpoints
- NGAL [ Time Frame: 5 days ] [ Designated as safety issue: No ]At selected trial sites will plasma and urinary NGAL be analysed at randomisation to assess the predictive value for dialyse and kidney failure
| Enrollment: | 804 |
| Study Start Date: | December 2009 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HES 130/0.4
Volume expansion
|
Drug: 6% Hydroxyethyl starch 130/0.4
Infusion for volume expansion in the ICU
Other Name: 6% Tetraspan
|
|
Active Comparator: Ringer acetate
Volume expansion
|
Drug: Ringers acetate
Infusion for volume expansion in the ICU
Other Name: Ringerfundin / Sterofundin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962156
Locations
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark | |
| Glostrup Hospital | |
| Copenhagen, Denmark | |
| Gentofte Hosptial | |
| Copenhagen, Denmark | |
| Bispebjerg Hospital | |
| Copenhagen, Denmark | |
| Herlev Hospital | |
| Copenhagen, Denmark | |
| Hvidovre Hospital | |
| Copenhagen, Denmark | |
| Esbjerg Hospital | |
| Esbjerg, Denmark | |
| Herning Hospital | |
| Herning, Denmark | |
| Hillerød Hospital | |
| Hillerød, Denmark | |
| Hjørring Hospital | |
| Hjørring, Denmark | |
| Holbæk Hospital | |
| Holbæk, Denmark | |
| Holstebro Hospital | |
| Holstebro, Denmark | |
| Køge Hospital | |
| Køge, Denmark | |
| Næstved Hospital | |
| Næstved, Denmark | |
| Odense University Hospital | |
| Odense, Denmark | |
| Slagelse Hospital | |
| Slagelse, Denmark | |
| Sønderborg Hospital | |
| Sønderborg, Denmark | |
| Vejle Hospital | |
| Vejle, Denmark | |
| Finland | |
| Dept of Intensive Care, Helsinki University Hospital | |
| Helsinki, Finland | |
| Dept. of Intensive Care, Kuopio University Hospital | |
| Kuopio, Finland | |
| Dept of Intensive Care, Tampere University Hospital | |
| Tampere, Finland | |
| Iceland | |
| Dept. of Intensive Care, Landspitali | |
| Reykjavik, Iceland | |
| Norway | |
| Haukeland University Hospital | |
| Bergen, Norway | |
| Stavanger University Hospital | |
| Stavanger, Norway | |
| Intensive Care Unit, University Hospital of North Norway | |
| Tromsø, Norway | |
| St Olavs Hospital, Trondheim University Hospital | |
| Trondheim, Norway | |
Sponsors and Collaborators
Anders Perner
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
B. Braun Melsungen AG
Investigators
| Principal Investigator: | Anders Perner, MD, PhD | ICU, Rigshospitalet, University of Copenhagen |
| Study Director: | Nicolai Haase, MD | Rigshospitalet, Denmark |
More Information
Additional Information:
Publications:
| Responsible Party: | Anders Perner, Chairman, Scandinavian Critical Care Trials Group |
| ClinicalTrials.gov Identifier: | NCT00962156 History of Changes |
| Other Study ID Numbers: | 2008-262, EudraCT no. 2009-010104-28 |
| Study First Received: | August 18, 2009 |
| Last Updated: | July 9, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Scandinavian Critical Care Trials Group:
|
Sepsis Shock Fluid therapy Plasma expanders |
Additional relevant MeSH terms:
|
Sepsis Toxemia Shock Shock, Septic Infection Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Hetastarch Plasma Substitutes Blood Substitutes Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013