Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.

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

Details

• Lead Sponsor: German Competence Network Sepsis; SepNet - Critical Care Trials Group
• Collaborators: B. Braun Melsungen AG; German Federal Ministry of Education and Research; HemoCue Gmbh, Großostheim, Germany; Novo Nordisk A/S
• Treatments: Hydroxyethyl Starch Derivatives; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission

Exclusion Criteria:

• Age < 18 years

• Pregnancy

• Known allergy against hydroxyethyl starch

• Pre-treatment with > 1000ml hydroxyethyl starch within 24 hours before inclusion

• Pre-existing kidney failure requiring dialysis or serum creatinine value > 320 mmol/l (3,6 mg/dl)

• Intracerebral hemorrhage

• Severe head trauma with edema

• FiO2 at time of study inclusion > 0,7

• Heart failure (New York Heart Association [NYHA] IV)

• Enrolment in another interventional study

• Immune suppression (cytostatic chemotherapy, steroid therapy, AIDS)

• Do not resuscitate (DNR) order