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Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

Information source: University of Versailles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock

Intervention: recombinant human insulin (Drug); hydrocortisone (Drug); fludrocortisone (Drug); Hydrocortisone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Versailles

Official(s) and/or principal investigator(s):
Djillali annane, MD, PhD, Study Chair, Affiliation: Assistance Publique Hôpitaux de Paris - University of Versailles

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

Clinical Details

Official title: Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: In-hospital mortality

Secondary outcome:

Secondary outcomes :

90-day and 180-day mortality.

Duration of life-supporting treatments (i.e. vasopressors and mechanical ventilation)

Time to resolve multiple organ dysfunction, i.e. to obtain a SOFA score < 8

Hospital length of stay.

Number of hypoglycaemic events (blood glucose < 4 mmol/l) during insulin infusion

Muscle weakness at discharge from intensive care unit, 90-day and 180-day

Post traumatic stress disorders

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 corticosteroids; and of efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone Methods Study design : This is a multicenter, prospective, randomised trial on parallel groups Study treatments : Experimental arm A: A1=50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days AND strict control of blood glucose levels with a target of 4,4 to 6 mmol/L using continuous iv infusion of insulin up to intensive care unit discharge. A2=50 mg iv every 6 hours of hydrocortisone (hemisuccinate) for 7 days AND strict control of blood glucose levels with a target of 4,4 to 6 mmol/L using continuous iv infusion of insulin up to intensive care unit discharge. Control arm B: B1: 50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days. B2: 50 mg iv every 6 hours of hydrocortisone (hemisuccinate)for 7 days. Study Primary outcome : In-hospital mortality Sample size calculation : The expected in-hospital mortality rate in the control group is 50%. To detect an absolute reduction in in-hospital mortality rate of 12. 5 %, that is 37. 5% in the experimental arm versus 50% in the control arm, and considering risk alpha of 0,05 and a risk beta of 0,20, 254 patients per treatment arms are needed, for a total of 508 patients.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 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 Criteria: One of the following :

- Pregnancy

- Less than 18 years old

- Moribund (i. e. expected to die on day of intensive care unit admission)

Locations and Contacts

Hôpital Avicenne, Bobigny, France

Hôpital Jean Verdier, Bondy, France

CHU Grenoble, Grenoble, France

Hôpital central, Nancy, France

Hôpital Bichat Claude Bernard, Paris, France

hôpital Cochin, Paris, France

Hôpital Saint Louis, Paris 75, France

Hôpital Delafontaine, Saint Denis 93, France

Additional Information

Starting date: January 2006
Last updated: April 5, 2010

Page last updated: August 23, 2015

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