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Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

NCT00320099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2010-04-06

No results posted yet for this study

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 corticosteroids. In addition, this study will compare the efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone

Conditions

  • Septic Shock

Interventions

DRUG

recombinant human insulin

intensive insulin therapy as a continuous infusion to maintain blood glucose levels between 4 and 6 mmol/l

DRUG

hydrocortisone

50 mg as iv bolus every 6 hours for 7 days

DRUG

fludrocortisone

50 µg once a day via a nasogastric tube for seven days

DRUG

Hydrocortisone

hydrocortisone 50mg q6 for 7 days

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • University of Versailles

    lead OTHER

Principal Investigators

  • Djillali annane, MD, PhD · Assistance Publique Hôpitaux de Paris - University of Versailles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00320099 on ClinicalTrials.gov