Status:
COMPLETED
Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)
Lead Sponsor:
SepNet - Critical Care Trials Group
Collaborating Sponsors:
German Federal Ministry of Education and Research
B. Braun Melsungen AG
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Severe sepsis and septic shock have a high mortality. Research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. In Europe the use of colloids ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00135473
Start Date
April 1 2003
End Date
September 1 2005
Last Update
February 11 2016
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum der RWTH Aachen
Aachen, Germany, 52074
2
Klinikum Augsburg
Augsburg, Germany, 86156
3
VIVANTES Klinikum Neukölln II
Berlin, Germany, 12313
4
Charité I Campus Virchow-Klinikum
Berlin, Germany, 13353