Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. (COCCA)
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| ClinicalTrials.gov Identifier: NCT03773822 |
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Recruitment Status :
Recruiting
First Posted : December 12, 2018
Last Update Posted : June 14, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiogenic Shock | Combination Product: Hydrocortisone + Flucortac Other: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 380 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study |
| Actual Study Start Date : | April 19, 2019 |
| Estimated Primary Completion Date : | April 20, 2023 |
| Estimated Study Completion Date : | August 20, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo of hydrocortisone and placebo of fludrocortisone
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
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Other: Placebo
Placebo |
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Experimental: Combination of hydrocortisone + fludrocortisone
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
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Combination Product: Hydrocortisone + Flucortac
Low dose steroids |
- Patients not treated with corticosteroids at day 7 [ Time Frame: 7 days ]
- Mortality at 28 and 90 days after randomisation [ Time Frame: 28 and 90 days after randomisation ]
- Modification of the cardiac index [ Time Frame: 7 days ]
- Length of stay in intensive care and hospital [ Time Frame: 28 and 90 days after randomisation ]
- Duration of support by catecholamines [ Time Frame: 28 days after randomisation ]
- Clearance of lactatemia [ Time Frame: 7 days ]
- Number of patients use of mechanical ventilation [ Time Frame: 28 days after randomisation ]
- Number of patients with Circulatory assistance [ Time Frame: 28 days after randomisation ]
- Number of patients alive at day 7 without failure (SOFA) score) [ Time Frame: 7 days ]
- Rate of patients with nosocomial infection [ Time Frame: 28 days after randomisation ]
- Rates of patients requiring the introduction of intravenous insulin therapy after randomization [ Time Frame: 7 days ]
- Modification of mean arterial pressure [ Time Frame: 7 days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged ≥18 years
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Cardiogenic shock state, according to the consensual definition:
- Systemic arterial hypertension (systolic blood pressure <90 mmHg or mean arterial pressure ≤ 65 mmHg) or signs of peripheral hypoperfusion, requiring treatment with catecholamines to maintain systolic blood pressure ≥ 90 mmHg and regression of signs of hypoperfusion;
- Presence of at least one sign of systemic hypoperfusion among the following: marbling, oliguria ≤ 25 ml / h, impairment of consciousness, arterial hyperlactatemia> 2 mmol / L;
- Presence of at least one sign of hypocontractility or low flow among the following: cardiac index ≤ 2.2 L / min / m2, left ventricular ejection fraction (LVEF) ≤ 40% or full time velocity (ITV) under aortic ≤ 18 cm, or need for catecholamines to maintain an index
- Clinical signs of left and / or right cardiac congestion (clinical sign of acute cardiogenic pulmonary edema or jugular turgor or edema of the lower limbs), radiological (bilateral alveolar opacities compatible with acute cardiogenic pulmonary edema), echocardiography (elevation of filling pressures of the left ventricle measured with Doppler: E / A> 2 if LVEF ≤40% or E / Ea> 13 if LVEF> 40%; or estimated PAPS> 35mmHg) or with right cardiac catheterization (pulmonary artery occlusion pressures> 15mmHg or PAPm> 25mmHg)
- Having received informed information about the study and having signed a consent to participate in the study
- Benefiting from a social security
Exclusion Criteria:
- Cardiogenic shock state with catecholamine infusion for more than 24 hours;
- Presence Presence of septic shock at inclusion;
- Cardiopulmonary arrest recovered in the 7 days preceding inclusion with at least one early sign of poor prognosis among the following: no control, non-shockable rhythm, CAHP score (Cardiac Arrest Hospital Prognosis)> 150;
- Patients already on circulatory support (ECMO) before inclusion (patients who are assisted after inclusion will not be excluded);
- Cardiogenic shock on viral myocarditis;
- Prior corticosteroid therapy (≥ 30 mg prednisone or equivalent ≥ 1 month);
- Receiving one of the following treatments: ketoconazole, rifampicin, phenytoin, phenobarbital, cyclosporine and clarithromycin;
- Known history of hypersensitivity to fludrocortisone or hydrocortisone;
- Known pregnancy or breastfeeding;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773822
| Contact: Armand MEKONTSO DESSAP, MD | (+33)1 46 25 24 33 | armand.dessap@aphp.fr | |
| Contact: François BAGATE,, MD | (+33)1 49 81 23 89 | francois.bagate@aphp.fr |
Show 21 study locations
| Responsible Party: | CMC Ambroise Paré |
| ClinicalTrials.gov Identifier: | NCT03773822 |
| Other Study ID Numbers: |
2018/05 |
| First Posted: | December 12, 2018 Key Record Dates |
| Last Update Posted: | June 14, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cardiogenic Shock Steroids Hydrocortisone Fludrocortisone |
Reversal of shock Mortality Adrenal insufficiency |
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Shock, Cardiogenic Shock Pathologic Processes Myocardial Infarction Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Infarction Ischemia Necrosis Hydrocortisone Anti-Inflammatory Agents |