Patient Admitted in ReanimationPhase 3NCT00862381
Hydrocortisone Use After Etomidate in Intensive Care
A Phase 3 study testing Hydrocortisone in people with Patient Admitted in Reanimation, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Patient Admitted in Reanimation
- What is being tested?
- Hydrocortisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2008to Jul 2010
- Phase
- Phase 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who received an unique injection of etomidate in pre-hospital situation or at "déchocage" in the previous 6 hours.
- informed consent signed by the patient or the reliable person
- affiliation to a regime of social security
Who cannot join
- persons aimed at the articles L. 1121-5 à L. 1121-8 of the french code of public health
- toxic shock requiring a treatment by HSHC inn accordance with the criteria of Annane et Al. [13]
- purpura fulminans
- chronicle suprarenal insufficiency
- patients likely to present an acute suprarenal insufficiency : current treatment with antifungal : ketoconazole or fluconazole, known HIV infection, Sheehan syndrome
- corticotherapy in the 6 last months
Show all 10Show fewer
- initiation of hydrocortisone therapy out of the study
- survival estimated at less than 48 hours
- no benefits of social security
- refusal to participate by patient or reliable person
Trial locations and contacts
2 sites in 1 country.
France2 sites
Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne
Annecy
Pôle d'anesthésie - réanimation, University Hospital of Grenoble
Grenoble
About this study
Official title: Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation
the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate
Read the detailed description
Etomidate is a hypnotic widely used for patients in intensive care who require rapid induction, because of its short duration of action, its excellent cardiovascular tolerance and maintenance of cerebral perfusion pressure.
For this reason etomidate remains the hypnotic of choice for induction of unstable patients. Other hypnotics currently in existence do not provide adequate safety with a sufficiently predictable and stable effect in this situation. However, it may induce acute adrenal insufficiency by inhibition of 11-b-hydroxylase necessary for the synthesis of cortisol from compound S. An observational study conducted at the Grenoble University hospital in 2006 showed that the duration of this blockage can reach up to 48 hours. Acute adrenal insufficiency in intensive care patients is associated with a poor prognosis. The main objective of this study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate.
This is an interventional, prospective, randomized, placebo-controlled, double-blind, analytical study with a cohort of 100 patients between 18 and 80 years, of both sexes, who have had tracheal intubation in a pre-hospital or shock treatment setting with the administration of a single injection of etomidate.
- Conditions
- Patient Admitted in Reanimation
- Being tested
- Hydrocortisone, Placebo
- Keywords
- shock, Tracheal Intubation, reanimation, suprarenal insufficiency, Etomidate, Adrenocorticotropic Hormone, hydrocortisone
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment
PlaceboDrug
NaCl 0.9%
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hydrocortisone Receives: Drug: Hydrocortisone |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
diminution of 50% of the proportion of patients with a score SOFA of 3 or 4
Measured: 12h, 24h and 48h after the injection of hydrocortisone
mean arterial blood pressure
Measured: during the hospitalisation
plasmatic cortisol and substance S before and after ACTH stimulation
Measured: h-4; h6; h12 and h24
Secondary outcomes (7)
clinical state
Measured: 12h and 24h
hospitalisation duration in reanimation
Measured: until day28
duration of mechanical ventilation
Measured: until day28
duration and posology of adrenaline and noradrenaline
Measured: h0, h4, h6, h12, h24 and h48
complications during hospitalization in reanimation potentially due to HSHC
Measured: until day28
dose of etomidate injection
Measured: h0
mortality
Measured: day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Admitted in ReanimationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- Christophe PH, BROUX, Principal investigator, University Hospital of Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862381
- Sponsor's protocol ID
- 0726
- Other IDs
- 2007-007603-32
- Status last verified
- Jul 2010
- First submitted
- 13 Mar 2009
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Payen JF, Dupuis C, Trouve-Buisson T, Vinclair M, Broux C, Bouzat P, Genty C, Monneret D, Faure P, Chabre O, Bosson JL. Corticosteroid after etomidate in critically ill patients: a randomized controlled trial. Crit Care Med. 2012 Jan;40(1):29-35. doi: 10.1097/CCM.0b013e31822d7938.
PubMed 21926601
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation
- ClinicalTrials.gov ID
- NCT00862381
- Acronym / sponsor ID
- 0726
- Conditions
- Patient Admitted in Reanimation
- Keywords
- shock, Tracheal Intubation, reanimation, suprarenal insufficiency, Etomidate, Adrenocorticotropic Hormone, hydrocortisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 16 Mar 2009 (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.
the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate
Detailed description
Etomidate is a hypnotic widely used for patients in intensive care who require rapid induction, because of its short duration of action, its excellent cardiovascular tolerance and maintenance of cerebral perfusion pressure.
For this reason etomidate remains the hypnotic of choice for induction of unstable patients. Other hypnotics currently in existence do not provide adequate safety with a sufficiently predictable and stable effect in this situation. However, it may induce acute adrenal insufficiency by inhibition of 11-b-hydroxylase necessary for the synthesis of cortisol from compound S. An observational study conducted at the Grenoble University hospital in 2006 showed that the duration of this blockage can reach up to 48 hours. Acute adrenal insufficiency in intensive care patients is associated with a poor prognosis. The main objective of this study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate.
This is an interventional, prospective, randomized, placebo-controlled, double-blind, analytical study with a cohort of 100 patients between 18 and 80 years, of both sexes, who have had tracheal intubation in a pre-hospital or shock treatment setting with the administration of a single injection of etomidate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HydrocortisoneHydrocortisone |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who received an unique injection of etomidate in pre-hospital situation or at "déchocage" in the previous 6 hours.
- informed consent signed by the patient or the reliable person
- affiliation to a regime of social security
Key exclusion criteria (10 listed)
- persons aimed at the articles L. 1121-5 à L. 1121-8 of the french code of public health
- toxic shock requiring a treatment by HSHC inn accordance with the criteria of Annane et Al. [13]
- purpura fulminans
- chronicle suprarenal insufficiency
- patients likely to present an acute suprarenal insufficiency : current treatment with antifungal : ketoconazole or fluconazole, known HIV infection, Sheehan syndrome
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 |
|---|---|---|
| Hydrocortisonehemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment | Drug | 1 |
| PlaceboNaCl 0.9% | Drug | 2 |
Primary outcome
diminution of 50% of the proportion of patients with a score SOFA of 3 or 4
Time frame: 12h, 24h and 48h after the injection of hydrocortisone
mean arterial blood pressure
Time frame: during the hospitalisation
plasmatic cortisol and substance S before and after ACTH stimulation
Time frame: h-4; h6; h12 and h24
7 secondary outcomes
clinical state
Time frame: 12h and 24h
hospitalisation duration in reanimation
Time frame: until day28
duration of mechanical ventilation
Time frame: until day28
duration and posology of adrenaline and noradrenaline
Time frame: h0, h4, h6, h12, h24 and h48
complications during hospitalization in reanimation potentially due to HSHC
Time frame: until day28
dose of etomidate injection
Time frame: h0
mortality
Time frame: day28
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 26 Jul 2010.
- Derived from this study: PubMed 21926601Payen JF, Dupuis C, Trouve-Buisson T, Vinclair M, Broux C, Bouzat P, Genty C, Monneret D, Faure P, Chabre O, Bosson JL. Corticosteroid after etomidate in critically ill patients: a randomized controlled trial. Crit Care Med. 2012 Jan;40(1):29-35. doi: 10.1097/CCM.0b013e31822d7938.
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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.
Christophe PH, BROUX principal investigator
University Hospital of Grenoble, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone in people with Patient Admitted in Reanimation, run by University Hospital, Grenoble at 2 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 3 inclusion and 10 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 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 phase mean?
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?
diminution of 50% of the proportion of patients with a score SOFA of 3 or 4 (time frame: 12h, 24h and 48h after the injection of hydrocortisone). The study lists 3 primary outcomes in all. 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 NCT00862381, which also lists 1 linked publication.
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 26 Jul 2010.