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Severe SepsisPhase 36SNCT00962156

Scandinavian Starch for Severe Sepsis/Septic Shock Trial

A Phase 3 study testing 6% Hydroxyethyl starch 130/0.4 and Ringers acetate in people with Severe Sepsis and Septic Shock, run by Anders Perner at 26 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Sepsis, Septic Shock
What is being tested?
6% Hydroxyethyl starch 130/0.4 and Ringers acetate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
804 participants
Where
26 sitesin 4 countries
Study dates
Dec 2009to Mar 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

26 sites in 4 countries.

26 sites in 4 countries

Denmark18 sites

  • Bispebjerg Hospital

    Copenhagen

  • Gentofte Hosptial

    Copenhagen

  • Glostrup Hospital

    Copenhagen

  • Herlev Hospital

    Copenhagen

  • Hvidovre Hospital

    Copenhagen

  • Rigshospitalet

    Copenhagen

  • Esbjerg Hospital

    Esbjerg

  • Herning Hospital

    Herning

  • Hillerød Hospital

    Hillerød

  • Hjørring Hospital

    Hjørring

  • Holbæk Hospital

    Holbæk

  • Holstebro Hospital

    Holstebro

  • Køge Hospital

    Køge

  • Næstved Hospital

    Næstved

  • Odense University Hospital

    Odense

  • Slagelse Hospital

    Slagelse

  • Sønderborg Hospital

    Sønderborg

  • Vejle Hospital

    Vejle

Other trials in Denmark

Norway4 sites

  • Haukeland University Hospital

    Bergen

  • Stavanger University Hospital

    Stavanger

  • Intensive Care Unit, University Hospital of North Norway

    Tromsø

  • St Olavs Hospital, Trondheim University Hospital

    Trondheim

Other trials in Norway

Finland3 sites

  • Dept of Intensive Care, Helsinki University Hospital

    Helsinki

  • Dept. of Intensive Care, Kuopio University Hospital

    Kuopio

  • Dept of Intensive Care, Tampere University Hospital

    Tampere

Other trials in Finland

Iceland1 site

  • Dept. of Intensive Care, Landspitali

    Reykjavik

Other trials in Iceland

About this study

Official title: 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.
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.

Being tested
6% Hydroxyethyl starch 130/0.4, Ringers acetate
Keywords
Sepsis, Shock, Fluid therapy, Plasma expanders
Medical subject headings
Sepsis, Shock, Septic, Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6% Hydroxyethyl starch 130/0.4Drug

    Also called 6% Tetraspan

    Infusion for volume expansion in the ICU

  • Ringers acetateDrug

    Also called Ringerfundin / Sterofundin

    Infusion for volume expansion in the ICU

Study groups in NCT00962156
Study groupRoleWhat they receive
HES 130/0.4ExperimentalVolume expansion
Receives: Drug: 6% Hydroxyethyl starch 130/0.4
Ringer acetateActive comparatorVolume expansion
Receives: Drug: Ringers acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality or dialysis-dependency

    Measured: 90 days

Secondary outcomes (13)

  1. Mortality

    Measured: 28 days

  2. Mortality

    Measured: 6 months

  3. Mortality

    Measured: 1 year

  4. Severity organ failure assessment score

    Excluding Glascow coma score

    Measured: Day 5

  5. Days free of ventilation

    Among survivors

    Measured: 90 days

  6. Days free of dialysis

    Among survivors

    Measured: 90 days

  7. Serious adverse reactions

    Severe bleeding or severe allergic reactions

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

  8. Need of dialysis/haemofiltration

    Measured: Within 90 days

  9. Need of ventilation

    Measured: Within 90 days

  10. Kidney failure

    Severity organ failure assessment score > 2 in the renal component

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

  11. Hospital length of stay

    Measured: 90 days

  12. Coagulation analyses

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

    Measured: 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

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
804 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00962156
Sponsor's protocol ID
2008-262
Other IDs
EudraCT no. 2009-010104-28
Acronym
6S
Status last verified
Jul 2012
First submitted
18 Aug 2009
Last updated
10 Jul 2012
Results posted
No
Data monitoring committee
Yes

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.

    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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 6% Hydroxyethyl starch 130/0.4 and Ringers acetate in people with Severe Sepsis and Septic Shock, run by Anders Perner at 26 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Denmark, Norway, Finland, Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality or dialysis-dependency (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00962156, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.

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