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Treatment of Polytraumatisms With Corticoids

Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00563303
Acronym
Hypolyte
Enrollment
150
Registered
2007-11-26
Start date
2006-11-01
Completion date
2009-07-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polytraumatism

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.

Interventions

DRUGhydrocortisone

200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6

DRUGNaCl

48mL from Day 1 to Day 6

Sponsors

Nantes University Hospital
Lead SponsorOTHER
Serb
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria28 days

Secondary

MeasureTime frame
Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.28 days
Incidence of nosocomial pneumopathyDay 8

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMahe Joachim, MD

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026