BurnsPhase 4NCT00149123
Low-dose Hydrocortisone in Acutely Burned Patients
A Phase 4 study testing hydrocortisone 200 mg/day in people with Burns, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burns
- What is being tested?
- hydrocortisone 200 mg/day
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2005to Oct 2010
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females,
- between 18 and 75 year old
- who present a burned surface more than 30% of the body surface
- who need catecholamine infusion
- between J0 and J3 after the injury.
Who cannot join
- pregnancy,
- trauma,
- sepsis,
- cardiac insufficiency,
- AIDS,
- etomidate administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients
Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. After the initial hypovolemic phase, patients with extensive burns often present a shock with increased cardiac output and reduced systemic vascular resistances. As described in septic shock, we test the hypothesis that low-dose hydrocortisone could decrease the duration of the shock period.
- Conditions
- Burns
- Being tested
- hydrocortisone 200 mg/day
- Keywords
- Burn, adrenal insufficiency, hydrocortisone, short corticotropin test
- Medical subject headings
- Burns, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisone 200 mg/dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
Secondary outcomes (3)
Duration of catecholamine administration
Doses of administered catecholamine
Adrenal insufficiency incidence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Sylvie TISSOT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149123
- Sponsor's protocol ID
- 2004.354
- Status last verified
- Oct 2007
- First submitted
- 6 Sep 2005
- Last updated
- 12 Feb 2015
- Results posted
- No
Publications
Plassais J, Venet F, Cazalis MA, Le Quang D, Pachot A, Monneret G, Tissot S, Textoris J. Transcriptome modulation by hydrocortisone in severe burn shock: ancillary analysis of a prospective randomized trial. Crit Care. 2017 Jun 16;21(1):158. doi: 10.1186/s13054-017-1743-9.
PubMed 28623938Venet F, Plassais J, Textoris J, Cazalis MA, Pachot A, Bertin-Maghit M, Magnin C, Rimmele T, Monneret G, Tissot S. Low-dose hydrocortisone reduces norepinephrine duration in severe burn patients: a randomized clinical trial. Crit Care. 2015 Jan 26;19(1):21. doi: 10.1186/s13054-015-0740-0.
PubMed 25619170
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients
- ClinicalTrials.gov ID
- NCT00149123
- Acronym / sponsor ID
- 2004.354
- Conditions
- Burns
- Keywords
- Burn, adrenal insufficiency, hydrocortisone, short corticotropin test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Sep 2005 (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.
Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. After the initial hypovolemic phase, patients with extensive burns often present a shock with increased cardiac output and reduced systemic vascular resistances. As described in septic shock, we test the hypothesis that low-dose hydrocortisone could decrease the duration of the shock period.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- males and females,
- between 18 and 75 year old
- who present a burned surface more than 30% of the body surface
- who need catecholamine infusion
- between J0 and J3 after the injury.
Key exclusion criteria (6 listed)
- pregnancy,
- trauma,
- sepsis,
- cardiac insufficiency,
- AIDS,
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 |
|---|---|---|
| hydrocortisone 200 mg/day | Drug | – |
Primary outcome
Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
3 secondary outcomes
Duration of catecholamine administration
Doses of administered catecholamine
Adrenal insufficiency incidence
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 12 Feb 2015.
- Derived from this study: PubMed 28623938Plassais J, Venet F, Cazalis MA, Le Quang D, Pachot A, Monneret G, Tissot S, Textoris J. Transcriptome modulation by hydrocortisone in severe burn shock: ancillary analysis of a prospective randomized trial. Crit Care. 2017 Jun 16;21(1):158. doi: 10.1186/s13054-017-1743-9.
- Derived from this study: PubMed 25619170Venet F, Plassais J, Textoris J, Cazalis MA, Pachot A, Bertin-Maghit M, Magnin C, Rimmele T, Monneret G, Tissot S. Low-dose hydrocortisone reduces norepinephrine duration in severe burn patients: a randomized clinical trial. Crit Care. 2015 Jan 26;19(1):21. doi: 10.1186/s13054-015-0740-0.
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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.
Sylvie TISSOT, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hydrocortisone 200 mg/day in people with Burns, run by Hospices Civils de Lyon at 1 site 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 5 inclusion and 6 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 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock. 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 NCT00149123, which also lists 2 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 12 Feb 2015; AzTrials last refreshed its copy on 6 Nov 2026.