Status:
COMPLETED
Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock
Lead Sponsor:
University of Versailles
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will compare, in adults with septic shock, the safety and efficacy of a combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticost...
Detailed Description
Objectives: Comparison, in patients with septic shock, of efficacy and safety of the combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of cortic...
Eligibility Criteria
Inclusion
- Patients admitted in intensive care units for septic shock and meeting all following criteria
- Proven infection
- Need for vasopressor to maintain systemic arterial tension above 90 mmHg
- Multiple organ dysfunction as defined by a SOFA score ³ 8.
- Need for treatment with moderate dose of corticosteroids
Exclusion
- One of the following :
- Pregnancy
- Less than 18 years old
- Moribund (i.e. expected to die on day of intensive care unit admission)
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT00320099
Start Date
January 1 2006
End Date
February 1 2009
Last Update
April 6 2010
Active Locations (8)
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1
Hôpital Avicenne
Bobigny, France
2
Hôpital Jean Verdier
Bondy, France
3
CHU Grenoble
Grenoble, France
4
Hôpital central
Nancy, France