Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007603-32 | Registry Identifier | ID RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Hydrocortisone |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone | Drug | hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| diminution of 50% of the proportion of patients with a score SOFA of 3 or 4 | 12h, 24h and 48h after the injection of hydrocortisone | |
| mean arterial blood pressure | during the hospitalisation | |
| plasmatic cortisol and substance S before and after ACTH stimulation | h-4; h6; h12 and h24 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical state | 12h and 24h | |
| hospitalisation duration in reanimation | until day28 | |
| duration of mechanical ventilation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christophe PH, BROUX | University Hospital of Grenoble, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne | Annecy | France | ||||
| Pôle d'anesthésie - réanimation, University Hospital of Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21926601 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012769 | Shock |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
NaCl 0.9% |
|
| until day28 |
| duration and posology of adrenaline and noradrenaline | h0, h4, h6, h12, h24 and h48 |
| complications during hospitalization in reanimation potentially due to HSHC | until day28 |
| dose of etomidate injection | h0 |
| mortality | day28 |
| Grenoble |
| France |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |