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Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled
Armand Mekontso Dessap1,2,3, François Bagate4,5,6, Clément Delmas7
1Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri-Mondor, Service de Médecine Intensive Réanimation, F-94010, Créteil, France. armand.dessap@aphp.fr.
Insights
This study investigates early low-dose corticosteroid therapy for cardiogenic shock (CS). It aims to determine if hydrocortisone and fludrocortisone improve shock reversal and patient outcomes in adults with CS.
Area of Science:
- Cardiology
- Intensive Care Medicine
- Endocrinology
Background:
- Cardiogenic shock (CS) is a critical condition of heart pump failure leading to circulatory insufficiency.
- CS involves tissue damage from low blood flow, including inflammation and adrenal axis dysfunction.
- Early intervention strategies for CS are crucial for improving patient survival.
Purpose of the Study:
- To evaluate the efficacy of early low-dose corticosteroid therapy in reversing cardiogenic shock in adult patients.
- To assess the impact of hydrocortisone and fludrocortisone on shock reversal and clinical outcomes.
- To provide evidence for a potential new therapeutic approach in managing CS.
Main Methods:
- A multicentered, randomized, double-blind, placebo-controlled trial involving 380 adult patients with CS.
- Patients received either hydrocortisone and fludrocortisone or a placebo for 7 days or until ICU discharge.
- The primary endpoint was the number of catecholamine-free days at day 7, with secondary endpoints including 28- and 90-day mortality.
Main Results:
- The study is designed to provide valuable evidence on the effectiveness of corticosteroid therapy for CS.
- Results will indicate whether this treatment improves shock reversal and reduces morbidity and mortality.
- Subgroup analyses will explore treatment effects in specific patient populations.
Conclusions:
- Early low-dose corticosteroid therapy shows potential as an effective treatment for cardiogenic shock.
- If proven effective, this regimen could become a standard therapeutic adjunct for CS patients.
- The trial aims to significantly impact the management and outcomes of cardiogenic shock.
Background:
Cardiogenic shock (CS) is a life-threatening condition characterized by circulatory insufficiency caused by an acute dysfunction of the heart pump. The pathophysiological approach to CS has recently been enriched by the tissue consequences of low flow, including inflammation, endothelial dysfunction, and alteration of the hypothalamic-pituitary-adrenal axis. The aim of the present trial is to evaluate the impact of early low-dose corticosteroid therapy on shock reversal in adults with CS.
Method/Design:
This is a multicentered randomized, double-blind, placebo-controlled trial with two parallel arms in adult patients with CS recruited from medical, cardiac, and polyvalent intensive care units (ICU) in France. Patients will be randomly allocated into the treatment or control group (1:1 ratio), and we will recruit 380 patients (190 per group). For the treatment group, hydrocortisone (50 mg intravenous bolus every 6 h) and fludrocortisone (50 μg once a day enterally) will be administered for 7 days or until discharge from the ICU. The primary endpoint is catecholamine-free days at day 7. Secondary endpoints include morbidity and all-cause mortality at 28 and 90 days post-randomization. Pre-defined subgroups analyses are planned, including: postcardiotomy, myocardial infarction, etomidate use, vasopressor use, and adrenal profiles according the short corticotropin stimulation test. Each patient will be followed for 90 days. All analyses will be conducted on an intention-to-treat basis.
Discussion:
This trial will provide valuable evidence about the effectiveness of low dose of corticosteroid therapy for CS. If effective, this therapy might improve outcome and become a therapeutic adjunct for patients with CS.
Trial Registration:
ClinicalTrials.gov , NCT03773822 . Registered on 12 December 2018.
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