Severe sepsis or septic shock MedDRA version: 13.1 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: PT Classification code 10053879 Term: Sepsis syndrome System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Tetraspan 6%
Pharmaceutical Form:
INN or Proposed INN: hydroxyethyl starch 130/0.42
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 6-
T
Sponsors
Dept. of Intensive Care, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: ·Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of HES 130/0.4 compared with a balanced crystalloid solution on mortality and end-stage kidney failure in patients with severe sepsis.;Secondary Objective: To assess the effects of HES 130/0.4 compared with a balanced crystalloid solution on · Sepsis-related organ failure assessment (SOFA, modified from (19), see Appendix 5) score (excluding Glasgow Coma Score) at day 5 after randomisation ·Kidney failure (SOFA score > 2 in the kidney component) at any time during the ICU stay after randomisation ·Development of kidney failure (doubling of p-creatinine values) during the ICU stay after randomisation ·Development of acidosis as the lowest recorded pHa during the ICU stay after randomisation ·Need of dialysis/haemofiltration ·Need of ventilation ·Days alive without dialysis/haemofiltration ·Days alive without ventilation ·Hospital length of stay for survivors;Primary end point(s): The composite outcome measure of 90-day mortality or end-stage kidney disease defined as dialysis-dependency 90 days after randomisation will be the primary outcome measure, and these two outcome measures will also be analysed separately | — |
Countries
Denmark, Finland, Iceland
Outcome results
None listed