Scandinavian Starch for Severe Sepsis/Septic Shock Trial

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anders Perner
• Collaborators: B. Braun Melsungen AG; Copenhagen Trial Unit, Center for Clinical Intervention Research; Rigshospitalet, Denmark; University of Copenhagen
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

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