Treatment of Polytraumatisms With Corticoids - Full Text View

Sponsor:	Nantes University Hospital
Collaborator:	Serb
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00563303

Purpose

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	Intervention	Phase
Polytraumatism	Drug: hydrocortisone Drug: NaCl	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency

Resource links provided by NLM:

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Incidence of nosocomial pneumopathy [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	November 2006
Study Completion Date:	July 2009
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563303

Locations

France
CHU Bordeaux
Bordeaux, France
CHU Morvan de Brest
Brest, France, 29609
CHU Caen
Caen, France
CH La Roche Sur Yon
La Roche Sur Yon, France
Hôtel Dieu
Nantes, France, 44093
CHU Pontchaillou
Rennes, France, 35033
CHU Trousseau
Tours, France, 37044

Sponsors and Collaborators

Nantes University Hospital

Serb

Investigators

Principal Investigator:

Mahe Joachim, MD

CHU de Nantes

More Information

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Roquilly A, Mahe PJ, Seguin P, Guitton C, Floch H, Tellier AC, Merson L, Renard B, Malledant Y, Flet L, Sebille V, Volteau C, Masson D, Nguyen JM, Lejus C, Asehnoune K. Hydrocortisone therapy for patients with multiple trauma: the randomized controlled HYPOLYTE study. JAMA. 2011 Mar 23;305(12):1201-9.

Responsible Party:	Pierre-joachim Mahé, investigator coordinator, CHu de Nantes
ClinicalTrials.gov Identifier:	NCT00563303 History of Changes
Other Study ID Numbers:	BRD 06/6-L, Afssaps: 060785, CPP: 2006/25
Study First Received:	September 26, 2006
Last Updated:	April 20, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Multiple Trauma
Wounds and Injuries
Cortisol succinate
Hydrocortisone acetate

Hydrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012