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CompletedNCT00563303HypolyteUpdated Sep 14, 2026

Treatment of Polytraumatisms With Corticoids

A Phase 2/3 interventional study of hydrocortisone and NaCl in Polytraumatism, sponsored by Nantes University Hospital. Completed at 7 sites in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Nantes University Hospital · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Polytraumatism

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03

In context

Multiple Trauma

139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.

This study's enrollment of 150 is above the median of 94 across 50 interventional studies indexed under Multiple Trauma.

Browse Multiple Trauma studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • History of corticothérapies within 6 months
  • History of adrenocortical insufficiency.
  • Treatment by immunosuppressor
  • Immunodeficiency.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    H

    Hydrocortisone

    Drug: hydrocortisone

  • Placebo comparator
    P

    Treatment by NaCl (placebo)

    Drug: NaCl

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

06

What researchers measure

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

07

Study locations

7 sites
  • CHU Bordeaux
    Bordeaux, France
  • CHU Morvan de Brest
    Brest, 29609, France
  • CHU Caen
    Caen, France
  • CH La Roche Sur Yon
    La Roche-sur-Yon, France
  • Hôtel Dieu
    Nantes, 44093, France
  • CHU Pontchaillou
    Rennes, 35033, France
  • CHU Trousseau
    Tours, 37044, France
08

References and documents

Publications

  • 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. doi: 10.1001/jama.2011.360. PubMed 21427372 ↗
  • Le Bras M, Roquilly A, Deckert V, Langhi C, Feuillet F, Sebille V, Mahe PJ, Bach K, Masson D, Lagrost L, Costet P, Asehnoune K, Cariou B. Plasma PCSK9 is a late biomarker of severity in patients with severe trauma injury. J Clin Endocrinol Metab. 2013 Apr;98(4):E732-6. doi: 10.1210/jc.2012-4236. Epub 2013 Feb 28. PubMed 23450051 ↗
  • Asehnoune K, Mahe PJ, Seguin P, Jaber S, Jung B, Guitton C, Chatel-Josse N, Subileau A, Tellier AC, Masson F, Renard B, Malledant Y, Lejus C, Volteau C, Sebille V, Roquilly A. Etomidate increases susceptibility to pneumonia in trauma patients. Intensive Care Med. 2012 Oct;38(10):1673-82. doi: 10.1007/s00134-012-2619-8. Epub 2012 Jul 10. PubMed 22777514 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2006, a primary completion of Nov 2006 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2006
First posted
Nov 26, 2007
Start
Nov 2006
Primary completionActual
Nov 2006
CompletionActual
Jul 2009
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00563303
Lead sponsor
Nantes University Hospital
Collaborators
Serb
First posted
Nov 26, 2007
Start date
Nov 2006
Primary completion
Nov 2006
Completion
Jul 2009
Last update
Sep 14, 2026

Study contacts

Mahe Joachim, MD
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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