Hypolyte: Treatment of Polytraumatisms With Corticoids

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00563303
• Collaborator: Serb (Other)
• Enrollment: 150
• Locations: 7
• Arms: 2
• Duration (Months): 32
• Patients Per Site: 21.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic complications and organs injuries.

Condition or Disease	Intervention/Treatment	Phase
Polytraumatism	Drug: hydrocortisone; Drug: NaCl	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: H Hydrocortisone	Drug: hydrocortisone; 200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6
Placebo Comparator: P Treatment by NaCl (placebo)	Drug: NaCl; 48mL from Day 1 to Day 6

Outcome Measures

Primary Outcome Measures

1. Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria [28 days]

Secondary Outcome Measures

1. Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc. [28 days]

2. Incidence of nosocomial pneumopathy [Day 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age superior of 15 years

• Hospitalization in reanimation for polytraumatism (lesion of two organs with a vital risk)

• SISS score more than 15

• Intubation for more than 48 hours.

• Agreement of a family member

• Patient with insurance

Exclusion Criteria:

• History of corticothérapies within 6 months

• History of adrenocortical insufficiency.

• Treatment by immunosuppressor

• Immunodeficiency.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Bordeaux	Bordeaux		France
2	CHU Morvan de Brest	Brest		France	29609
3	CHU Caen	Caen		France
4	CH La Roche Sur Yon	La Roche Sur Yon		France
5	Hôtel Dieu	Nantes		France	44093
6	CHU Pontchaillou	Rennes		France	35033
7	CHU Trousseau	Tours		France	37044

Sponsors and Collaborators

• Nantes University Hospital
• Serb

Investigators

• Principal Investigator: Mahe Joachim, MD, CHU de Nantes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00563303
• Other Study ID Numbers: BRD 06/6-L; Afssaps: 060785; CPP: 2006/25
• First Posted: Nov 26, 2007
• Last Update Posted: Apr 23, 2010
• Last Verified: Apr 1, 2010

• Additional relevant MeSH terms: Multiple Trauma; Hydrocortisone

Study Results

No Results Posted as of Apr 23, 2010