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Completed

NCT Number: NCT00563303

Treatment of Polytraumatisms With Corticoids

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.

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Key information

Conditions

Polytraumatism Multiple Trauma Wounds and Injuries

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrocortisone

Drug

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

NaCl

Drug

48mL from Day 1 to Day 6

Primary outcomes

  1. Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria

    Time frame: 28 days

Secondary outcomes

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

    Time frame: 28 days

  2. Incidence of nosocomial pneumopathy

    Time frame: Day 8

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Serb

Registry information

Official study title

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

Acronym: Hypolyte

Important dates

Study start
2006
Primary completion
2006
Study completion
2009
First posted
Nov 26, 2007
Registry last updated
Apr 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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