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CompletedNCT009621566SUpdated Jul 10, 2012

Scandinavian Starch for Severe Sepsis/Septic Shock Trial

A Phase 3 interventional study of 6% Hydroxyethyl starch 130/0.4 and Ringers acetate in Severe Sepsis and Septic Shock, sponsored by Anders Perner. Completed at 26 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-10.

Primary conditionShock, SepticRegistry: SepsisReclassifiedWhy we changed it
Registry
Sepsis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Shock, Septic
Why
  1. The study's listed conditions name Shock, Septic, a narrower term within Sepsis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Anders Perner · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
804
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Severe Sepsis
  • Septic Shock

Browse trials for

Keywords

  • Sepsis
  • Shock
  • Fluid therapy
  • Plasma expanders
03

In context

Shock, Septic Reclassified

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's enrollment of 804 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Anders Perner is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
804 participants (actual)

Study arms

  • Experimental
    HES 130/0.4

    Volume expansion

    Drug: 6% Hydroxyethyl starch 130/0.4

  • Active comparator
    Ringer acetate

    Volume expansion

    Drug: Ringers acetate

Interventions

  • Drug6% Hydroxyethyl starch 130/0.4

    Drug page: Hydroxyethyl Starch Derivatives

    Infusion for volume expansion in the ICU

    Also known as: 6% Tetraspan

  • DrugRingers acetate

    Infusion for volume expansion in the ICU

    Also known as: Ringerfundin / Sterofundin

06

What researchers measure

Primary outcomes

  1. Mortality or dialysis-dependency

    Time frame: 90 days

Secondary outcomes

  1. Mortality

    Time frame: 28 days

  2. Mortality

    Time frame: 6 months

  3. Mortality

    Time frame: 1 year

  4. Severity organ failure assessment score

    Excluding Glascow coma score

    Time frame: Day 5

  5. Days free of ventilation

    Among survivors

    Time frame: 90 days

  6. Days free of dialysis

    Among survivors

    Time frame: 90 days

  7. Serious adverse reactions

    Severe bleeding or severe allergic reactions

    Time frame: Followed up until ICU discharge; consequently the time frame will vary among patients

  8. Need of dialysis/haemofiltration

    Time frame: Within 90 days

  9. Need of ventilation

    Time frame: Within 90 days

  10. Kidney failure

    Severity organ failure assessment score \> 2 in the renal component

    Time frame: Followed up until ICU discharge; consequently the time frame will vary among patients

  11. Hospital length of stay

    Time frame: 90 days

  12. Coagulation analyses

    At selected hospitals whole-blood and biochemical coagulation analyses constitute additional secondary endpoints

    Time frame: 5 days

  13. NGAL

    At selected trial sites will plasma and urinary NGAL be analysed at randomisation to assess the predictive value for dialyse and kidney failure

    Time frame: 5 days

07

Study locations

26 sites
  • 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
  • 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
  • Dept. of Intensive Care, Landspitali
    Reykjavik, Iceland
  • 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
08

References and documents

Publications

  • Perner A, Haase N, Wetterslev J, Aneman A, Tenhunen J, Guttormsen AB, Klemenzson G, Pott F, Bodker KD, Badstolokken PM, Bendtsen A, Soe-Jensen P, Tousi H, Bestle M, Pawlowicz M, Winding R, Bulow HH, Kancir C, Steensen M, Nielsen J, Fogh B, Madsen KR, Larsen NH, Carlsson M, Wiis J, Petersen JA, Iversen S, Schoidt O, Leivdal S, Berezowicz P, Pettila V, Ruokonen E, Klepstad P, Karlsson S, Kaukonen M, Rutanen J, Karason S, Kjaeldgaard AL, Holst LB, Wernerman J; Scandinavian Critical Care Trials Group. Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S--Scandinavian Starch for Severe Sepsis/Septic Shock trial): study protocol, design and rationale for a double-blinded, randomised clinical trial. Trials. 2011 Jan 27;12:24. doi: 10.1186/1745-6215-12-24. PubMed 21269526 ↗
  • Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27. Erratum In: N Engl J Med. 2012 Aug 2;367(5):481. PubMed 22738085 ↗
  • Ostrowski SR, Haase N, Muller RB, Moller MH, Pott FC, Perner A, Johansson PI. Association between biomarkers of endothelial injury and hypocoagulability in patients with severe sepsis: a prospective study. Crit Care. 2015 Apr 24;19(1):191. doi: 10.1186/s13054-015-0918-5. PubMed 25907781 ↗
  • Perner A, Haase N, Winkel P, Guttormsen AB, Tenhunen J, Klemenzson G, Muller RG, Aneman A, Wetterslev J. Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer's acetate. Intensive Care Med. 2014 Jul;40(7):927-34. doi: 10.1007/s00134-014-3311-y. Epub 2014 May 8. PubMed 24807084 ↗
  • Muller RG, Haase N, Wetterslev J, Perner A. Effects of hydroxyethyl starch in subgroups of patients with severe sepsis: exploratory post-hoc analyses of a randomised trial. Intensive Care Med. 2013 Nov;39(11):1963-71. doi: 10.1007/s00134-013-3090-x. Epub 2013 Sep 14. PubMed 24037226 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00962156
Lead sponsor
Anders Perner
Collaborators
Rigshospitalet, Denmark, Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen, B. Braun Melsungen AG
Responsible party
Anders Perner (Chairman, Scandinavian Critical Care Trials Group) — Sponsor-investigator
First posted
Aug 19, 2009
Start date
Dec 2009
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Jul 10, 2012

Study contacts

Anders Perner, MD, PhD
principal investigator · ICU, Rigshospitalet, University of Copenhagen
Nicolai Haase, MD
study director · Rigshospitalet, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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