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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00962156
First received: August 18, 2009
Last updated: July 9, 2012
Last verified: July 2012

August 18, 2009
July 9, 2012
December 2009
March 2012   (final data collection date for primary outcome measure)
Mortality or dialysis-dependency [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00962156 on ClinicalTrials.gov Archive Site
  • 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
28-day, 6-month and 1-year mortality, SOFA score at day 5, Kidney failure in the ICU, Development of kidney failure in the ICU, Need of dialysis or ventilation, Days alive without dialysis or ventilation at 90 days, Hospital length of stay for survivors [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Scandinavian Starch for Severe Sepsis/Septic Shock Trial
Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis
  • 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Severe Sepsis
  • Septic Shock
  • Drug: 6% Hydroxyethyl starch 130/0.4
    Infusion for volume expansion in the ICU
    Other Name: 6% Tetraspan
  • Drug: Ringers acetate
    Infusion for volume expansion in the ICU
    Other Name: Ringerfundin / Sterofundin
  • Experimental: HES 130/0.4
    Volume expansion
    Intervention: Drug: 6% Hydroxyethyl starch 130/0.4
  • Active Comparator: Ringer acetate
    Volume expansion
    Intervention: Drug: Ringers acetate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
804
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Iceland,   Norway
 
NCT00962156
2008-262, EudraCT no. 2009-010104-28
Yes
Anders Perner, Scandinavian Critical Care Trials Group
Anders Perner
  • Rigshospitalet, Denmark
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • University of Copenhagen
  • B. Braun Melsungen AG
Principal Investigator: Anders Perner, MD, PhD ICU, Rigshospitalet, University of Copenhagen
Study Director: Nicolai Haase, MD Rigshospitalet, Denmark
Scandinavian Critical Care Trials Group
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP