Status:
COMPLETED
Scandinavian Starch for Severe Sepsis/Septic Shock Trial
Lead Sponsor:
Anders Perner
Collaborating Sponsors:
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 sever...
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 sta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
804 Patients enrolled
Trial Details
Trial ID
NCT00962156
Start Date
December 1 2009
End Date
March 1 2012
Last Update
July 10 2012
Active Locations (26)
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1
Bispebjerg Hospital
Copenhagen, Denmark
2
Gentofte Hosptial
Copenhagen, Denmark
3
Glostrup Hospital
Copenhagen, Denmark
4
Herlev Hospital
Copenhagen, Denmark