Effects of hydroxyethyl starch 130/0.4 compared to a balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis - The 6S Trial

Phase 1

• Conditions: Severe sepsis or septic shock; MedDRA version: 9.1Level: LLTClassification code 10040070Term: Septic shock; MedDRA version: 9.1Level: LLTClassification code 10053879Term: Sepsis syndrome

• Registration Number: EUCTR2009-010104-28-FI
• Lead Sponsor: Dept. of Intensive Care, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-10
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

All adult patients who
·Undergo resuscitation in the ICU

·AND fulfilment within the previous 24 hours of the criteria for severe sepsis according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP), see Appendix 1

·AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Age < 18 years
·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 > 6.0 mM
·Liver or kidney transplantation during current hospital admission
·Intracranial bleeding within current hospitalisation
·Enrolment into another ICU trial of drugs with potential action on circulation, renal function or coagulation
·Withdrawal of active therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified