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Scandinavian Starch for Severe Sepsis/Septic Shock Trial (6S)

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ClinicalTrials.gov Identifier: NCT00962156
Recruitment Status : Completed
First Posted : August 19, 2009
Last Update Posted : July 10, 2012
Sponsor:
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

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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Drug: 6% Hydroxyethyl starch 130/0.4 Drug: Ringers acetate Phase 3

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.


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mortality or dialysis-dependency [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
  2. Mortality [ Time Frame: 6 months ]
  3. Mortality [ Time Frame: 1 year ]
  4. Severity organ failure assessment score [ Time Frame: Day 5 ]
    Excluding Glascow coma score

  5. Days free of ventilation [ Time Frame: 90 days ]
    Among survivors

  6. Days free of dialysis [ Time Frame: 90 days ]
    Among survivors

  7. Serious adverse reactions [ Time Frame: Followed up until ICU discharge; consequently the time frame will vary among patients ]
    Severe bleeding or severe allergic reactions

  8. Need of dialysis/haemofiltration [ Time Frame: Within 90 days ]
  9. Need of ventilation [ Time Frame: Within 90 days ]
  10. 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

  11. Hospital length of stay [ Time Frame: 90 days ]
  12. Coagulation analyses [ Time Frame: 5 days ]
    At selected hospitals whole-blood and biochemical coagulation analyses constitute additional secondary endpoints

  13. 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, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Gentofte Hosptial
Copenhagen, Denmark
Glostrup Hospital
Copenhagen, Denmark
Herlev Hospital
Copenhagen, Denmark
Hvidovre Hospital
Copenhagen, Denmark
Rigshospitalet
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

Publications of Results:
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     History of Changes
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

Keywords provided by Anders Perner, 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
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes