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

Anders Perner

Status and phase

Completed

Phase 3

Conditions

Severe Sepsis

Septic Shock

Treatments

Drug: 6% Hydroxyethyl starch 130/0.4

Drug: Ringers acetate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00962156

2008-262

EudraCT no. 2009-010104-28

Details and patient eligibility

About

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.

Full 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.

Enrollment

804 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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