Scandinavian Starch for Severe Sepsis/Septic Shock Trial (6S)
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| ClinicalTrials.gov Identifier: NCT00962156 |
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Recruitment Status :
Completed
First Posted : August 19, 2009
Last Update Posted : July 10, 2012
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- 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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Severe Sepsis Septic Shock | Drug: 6% Hydroxyethyl starch 130/0.4 Drug: Ringers acetate | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 804 participants |
| 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 |
| Study Start Date : | December 2009 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | March 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: HES 130/0.4
Volume expansion
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Drug: 6% Hydroxyethyl starch 130/0.4
Infusion for volume expansion in the ICU
Other Name: 6% Tetraspan |
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Active Comparator: Ringer acetate
Volume expansion
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Drug: Ringers acetate
Infusion for volume expansion in the ICU
Other Name: Ringerfundin / Sterofundin |
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962156
Show 26 study locations
| Principal Investigator: | Anders Perner, MD, PhD | ICU, Rigshospitalet, University of Copenhagen | |
| Study Director: | Nicolai Haase, MD | Rigshospitalet, Denmark |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anders Perner, Chairman, Scandinavian Critical Care Trials Group |
| ClinicalTrials.gov Identifier: | NCT00962156 |
| Other Study ID Numbers: |
2008-262 EudraCT no. 2009-010104-28 |
| First Posted: | August 19, 2009 Key Record Dates |
| Last Update Posted: | July 10, 2012 |
| Last Verified: | July 2012 |
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Sepsis Shock Fluid therapy Plasma expanders |
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Sepsis Toxemia Shock, Septic Shock Infections Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Hydroxyethyl Starch Derivatives Plasma Substitutes Blood Substitutes |