Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00320099
• Date of registration: 27/04/2006
• Prospective Registration: No
• Primary sponsor: University of Versailles
• Public title: Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock COIITSS
• Scientific title: Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock
• Date of first enrolment: January 2006
• Target sample size: 508
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00320099
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Djillali annane, MD, PhD
• Affiliation: Assistance Publique Hôpitaux de Paris - University of Versailles

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Septic Shock

Intervention(s)

Drug: fludrocortisone

Drug: recombinant human insulin

Drug: hydrocortisone

Primary Outcome(s)

In-hospital mortality [Time Frame: Day 180]

Secondary Outcome(s)

90-day and 180-day mortality. [Time Frame: Day 180]

Time to resolve multiple organ dysfunction, i.e. to obtain a SOFA score < 8 [Time Frame: Day 180]

Duration of life-supporting treatments (i.e. vasopressors and mechanical ventilation) [Time Frame: Day 180]

Secondary outcomes : [Time Frame: Day 180]

Muscle weakness at discharge from intensive care unit, 90-day and 180-day [Time Frame: Day 180]

Number of hypoglycaemic events (blood glucose < 4 mmol/l) during insulin infusion [Time Frame: Day 180]

Post traumatic stress disorders [Time Frame: Day 180]

Hospital length of stay. [Time Frame: Day 180]

Secondary ID(s)

AOM04100

P040421

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Assistance Publique - Hôpitaux de Paris