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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
380
Low dose steroids
Placebo
Hôpital Parly II
Le Chesnay, Le Chasnay, France
CH Intercommunal de Villeneuve Saint Georges
Villeneuve-Saint-Georges, Villeneuve Saint Georges, France
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital Ambroise Paré
Boulogne-Billancourt, France
CH de Marne la Vallée - Site Jossigny
Jossigny, France
CHU Lille - Institut Cœur Poumon
Lille, France
Centre Hospitalier Saint Joseph Saint Luc
Lyon, France
Hôpital Privé Jacques Cartier
Massy, France
Hôpital Arnaud-de-Villeneuve
Montpellier, France
CMC Ambroise Paré
Neuilly-sur-Seine, France
CHU de Nîmes
Nîmes, France
...and 11 more locations
Time frame: 7 days