Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock.

  • STATUS
    Recruiting
  • End date
    Jul 20, 2022
  • participants needed
    380
  • sponsor
    CMC Ambroise Paré
Updated on 6 August 2021
Investigator
Armand Mekontso Dessap, MD, PhD
Primary Contact
CH Intercommunal de Villeneuve Saint Georges (8.4 mi away) Contact
+36 other location
hypoperfusion
ejection fraction
systolic blood pressure
pulmonary congestion
congestion
catecholamines
oliguria
pulmonary artery occlusion

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 shock.

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 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 g/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.

Details
Condition Cardiogenic shock
Treatment Placebo, Hydrocortisone + Flucortac
Clinical Study IdentifierNCT03773822
SponsorCMC Ambroise Paré
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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
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