Status:
COMPLETED
Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock.
Lead Sponsor:
CMC Ambroise Paré
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 shoc...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Aged ≥18 years
- 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
- 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;
Key Trial Info
Start Date :
April 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2023
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT03773822
Start Date
April 19 2019
End Date
April 5 2023
Last Update
November 7 2023
Active Locations (21)
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1
Hôpital Parly II
Le Chesnay, Le Chasnay, France, 78150
2
CH Intercommunal de Villeneuve Saint Georges
Villeneuve-Saint-Georges, Villeneuve Saint Georges, France, 94190
3
Hôpital Ambroise Paré
Boulogne-Billancourt, France, 92100
4
CH de Marne la Vallée - Site Jossigny
Jossigny, France, 77600