Scandinavian Starch for Severe Sepsis/Septic Shock Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

804 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-03-31

Brief Summary

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* 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.

Detailed Description

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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.

Conditions

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Severe Sepsis Septic Shock

Keywords

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Sepsis Shock Fluid therapy Plasma expanders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HES 130/0.4

Volume expansion

Group Type EXPERIMENTAL

6% Hydroxyethyl starch 130/0.4

Intervention Type DRUG

Infusion for volume expansion in the ICU

Ringer acetate

Volume expansion

Group Type ACTIVE_COMPARATOR

Ringers acetate

Intervention Type DRUG

Infusion for volume expansion in the ICU

Interventions

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6% Hydroxyethyl starch 130/0.4

Infusion for volume expansion in the ICU

Intervention Type DRUG

Ringers acetate

Infusion for volume expansion in the ICU

Intervention Type DRUG

Other Intervention Names

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6% Tetraspan Ringerfundin / Sterofundin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Anders Perner

Chairman

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anders Perner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ICU, Rigshospitalet, University of Copenhagen

Nicolai Haase, MD

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

EudraCT no. 2009-010104-28

Identifier Type: -

Identifier Source: secondary_id

2008-262

Identifier Type: -

Identifier Source: org_study_id

Scandinavian Starch for Severe Sepsis/Septic Shock Trial

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

HES 130/0.4

6% Hydroxyethyl starch 130/0.4

Ringer acetate

Ringers acetate

Interventions

6% Hydroxyethyl starch 130/0.4

Ringers acetate

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Rigshospitalet, Denmark

Copenhagen Trial Unit, Center for Clinical Intervention Research

University of Copenhagen

B. Braun Melsungen AG

Anders Perner

Responsible Party

Anders Perner

Principal Investigators

Anders Perner, MD, PhD

Nicolai Haase, MD

Locations

Bispebjerg Hospital

Gentofte Hosptial

Glostrup Hospital

Herlev Hospital

Hvidovre Hospital

Rigshospitalet

Esbjerg Hospital

Herning Hospital

Hillerød Hospital

Hjørring Hospital

Holbæk Hospital

Holstebro Hospital

Køge Hospital

Næstved Hospital

Odense University Hospital

Slagelse Hospital

Sønderborg Hospital

Vejle Hospital

Dept of Intensive Care, Helsinki University Hospital

Dept. of Intensive Care, Kuopio University Hospital

Dept of Intensive Care, Tampere University Hospital

Dept. of Intensive Care, Landspitali

Haukeland University Hospital

Stavanger University Hospital

Intensive Care Unit, University Hospital of North Norway

St Olavs Hospital, Trondheim University Hospital

Countries

References

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.

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.

Related Links

Other Identifiers

EudraCT no. 2009-010104-28

2008-262