PolytraumatismPhase 2/3HypolyteNCT00563303
Treatment of Polytraumatisms With Corticoids
A Phase 2/3 study testing hydrocortisone and NaCl in people with Polytraumatism, run by Nantes University Hospital at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Polytraumatism
- What is being tested?
- hydrocortisone and NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 7 sitesFrance
- Study dates
- Nov 2006to Jul 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of corticothérapies within 6 months
- History of adrenocortical insufficiency.
- Treatment by immunosuppressor
- Immunodeficiency.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Bordeaux
Bordeaux
CHU Morvan de Brest
Brest, 29609
CHU Caen
Caen
CH La Roche Sur Yon
La Roche-sur-Yon
Hôtel Dieu
Nantes, 44093
CHU Pontchaillou
Rennes, 35033
CHU Trousseau
Tours, 37044
About this study
Official title: Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency
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.
- Conditions
- Polytraumatism
- Being tested
- hydrocortisone, NaCl
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6
NaClDrug
48mL from Day 1 to Day 6
| Study group | Role | What they receive |
|---|---|---|
| H | Experimental | Hydrocortisone Receives: Drug: hydrocortisone |
| P | Placebo comparator | Treatment by NaCl (placebo) Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria
Measured: 28 days
Secondary outcomes (2)
Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.
Measured: 28 days
Incidence of nosocomial pneumopathy
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startNov 2006
- Primary completionNov 2006
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PolytraumatismStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Serb
- Investigators
- Mahe Joachim, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563303
- Sponsor's protocol ID
- BRD/06/06-L
- Other IDs
- Afssaps: 060785, CPP: 2006/25
- Acronym
- Hypolyte
- Status last verified
- Apr 2010
- First submitted
- 26 Sep 2006
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
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 21427372Le 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 23450051Asehnoune 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency
- ClinicalTrials.gov ID
- NCT00563303
- Acronym / sponsor ID
- Hypolyte / BRD/06/06-L
- Conditions
- Polytraumatism
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Serb
- Study start
- Nov 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H | Experimental | Drug: hydrocortisoneHydrocortisone |
| P | Placebo comparator | Drug: NaClTreatment by NaCl (placebo) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- History of corticothérapies within 6 months
- History of adrenocortical insufficiency.
- Treatment by immunosuppressor
- Immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocortisone200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6 | Drug | H |
| NaCl48mL from Day 1 to Day 6 | Drug | P |
Primary outcome
Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria
Time frame: 28 days
2 secondary outcomes
Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.
Time frame: 28 days
Incidence of nosocomial pneumopathy
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 21427372Roquilly 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.
- Derived from this study: PubMed 23450051Le 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.
- Derived from this study: PubMed 22777514Asehnoune 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.
Related trials for Polytraumatism
Not yet recruitingObservational study
Medical,Nursing Record,PE, Blood Test and Radiological Examination ,Morality and Mobility of Multiple Trauma Patient
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
RecruitingObservational study
Collecting the Results of Multiple Trauma Patients and Find the Correlation of Morality and Mobility
Multiple Trauma/Injuries
Not yet recruiting
Sleep MAPP in the Polytrauma/TBI System of Care
Insomnia Disorder, Mild Traumatic Brain Injury
Active, not recruitingObservational study
Machine Learning to Predict Factors Affecting Rehabilitation Length of Stay and Healthcare Costs for Neurological Rehabilitation
Stroke, Acquired Brain Injury
RecruitingObservational study
IMMUNOREA - Immunological and Inflammatory Determinants Associated With the Prognosis of Intensive Care Patients
Critical Illness, Intensive Care Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahe Joachim, MD principal investigator
Nantes University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hydrocortisone and NaCl in people with Polytraumatism, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00563303, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.