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The purpose of this randomized controlled trial is to evaluate the hemodynamic effect of low dose corticosteroid therapy (hydrocortisone and fludrocortisone) in the treatment of adult cardiogenic shock.
Cardiogenic shock is a serious condition with a high mortality rate, characterized by acute dysfunction of the heart pump. Critical illness-related corticosteroid insufficiency is a pathophysiological concept, first described in septic shock. It is characterized by an impairment of the hypothalamic pituitary axis during critical illness. Its diagnosis is usually suggested by an inappropriate response to the adrenal stimulation test. The results of corticosteroid supplementation studies in septic shock are controversial, but most of these studies demonstrate that corticosteroid therapy improves reversal of shock.
The concept of critical illness-related corticosteroid insufficiency has recently been expanded to cardiogenic shock. The latter has many physiopathological similarities with septic shock. However, no studies have evaluated the effect of supplemental corticosteroid supplementation in cardiogenic shock.
The purpose of this study is to evaluate the hemodynamic effect of low dose corticosteroid therapy in the treatment of adult cardiogenic shock.
This study is a multicenter, randomized, double blinded, placebo controlled trial comparing intravenous hydrocortisone (50 mg intravenously every 6 hours) plus enteral fludrocortisone (50 µg/day) with placebo for seven days in critically ill patients with cardiogenic shock.
The primary endpoint for this trial will be catecholamine-fee days at day-7. Secondary endpoints will include all-cause mortality at 28 and 90 days after randomisation.
Several pre-defined sub-groups analyses are planned, including: postcardiotomy, myocardial infarction, etomidate use, vasopressor use...
380 patients will be enrolled in this study at approximately 20 study sites. Each patient will be followed-up for 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo of hydrocortisone and placebo of fludrocortisone | Placebo Comparator | Placebo of hydrocortisone as an iv bolus every 6 hours for seven days plus placebo of enteral fludrocortisone given once a day for seven days |
|
| Combination of hydrocortisone + fludrocortisone | Experimental | Hydrocortisone will be given as 50 mg iv bolus every 6 hours for seven days and a tablet of 50 µg of fludrocortisone will be given once a day enterally for seven days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone + Flucortac | Combination Product | Low dose steroids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days alive and free of catecholamine support through day 7 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 28 and 90 days after randomisation | 28 and 90 days after randomisation | |
| Modification of the cardiac index | 7 days | |
| Length of stay in intensive care and hospital |
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Inclusion Criteria:
Aged ≥18 years
Cardiogenic shock state, according to the consensual definition:
Having received informed information about the study and having signed a consent to participate in the study
Benefiting from a social security
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Ambroise Paré | Boulogne-Billancourt | Boulogne-Billancourt | 92100 | France | ||
| CH de Marne la Vallée - Site Jossigny |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34980224 | Derived | Mekontso Dessap A, Bagate F, Delmas C, Morichau-Beauchant T, Cholley B, Cariou A, Lattuca B, Moussa M, Mongardon N, Fard D, Schmidt M, Bougle A, Kerneis M, Vivier E, Roubille F, Duprey M, Decalf V, Genet T, Merzoug M, Audureau E, Squara P. Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial. Trials. 2022 Jan 3;23(1):4. doi: 10.1186/s13063-021-05947-6. |
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| Placebo | Other | Placebo |
|
| 28 and 90 days after randomisation |
| Duration of support by catecholamines | 28 days after randomisation |
| Clearance of lactatemia | 7 days |
| Number of patients use of mechanical ventilation | 28 days after randomisation |
| Number of patients with Circulatory assistance | 28 days after randomisation |
| Number of patients alive at day 7 without failure (SOFA) score) | 7 days |
| Rate of patients with nosocomial infection | 28 days after randomisation |
| Rates of patients requiring the introduction of intravenous insulin therapy after randomization | 7 days |
| Modification of mean arterial pressure | 7 days |
| Jossigny |
| Jossigny |
| 77600 |
| France |
| Hôpital Parly II | Le Chesnay | Le Chasnay | 78150 | France |
| Hôpital Privé Jacques Cartier | Massy | Massy | 91300 | France |
| CHU de Strasbourg | Strasbourg | Strasbourg | 67000 | France |
| CH Intercommunal de Villeneuve Saint Georges | Villeneuve-Saint-Georges | Villeneuve Saint Georges | 94190 | France |
| CHU Lille - Institut Cœur Poumon | Lille | 59000 | France |
| Centre Hospitalier Saint Joseph Saint Luc | Lyon | 69007 | France |
| Hôpital Arnaud-de-Villeneuve | Montpellier | 34090 | France |
| CMC Ambroise Paré | Neuilly-sur-Seine | 92200 | France |
| CHU de Nîmes | Nîmes | 30029 | France |
| Hôpitaux Universitaires Pitié Salpêtrière | Paris | 75013 | France |
| Groupe Hospitalier Paris Saint Joseph | Paris | 75014 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Hôpital européen Georges-Pompidou | Paris | 75015 | France |
| Hôpital Bichat | Paris | 75018 | France |
| CH Pontoise | Pontoise | 95300 | France |
| Centre cardiologique du nord saint denis | Saint-Denis | 93200 | France |
| Hopital Rangueil | Toulouse | 31400 | France |
| CHRU Hôpitaux de Tours | Tours | 37000 | France |
| Hôpital Henri Mondor | Paris | Île-de-France Region | France |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | 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 |
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