Clinical Trials Logo
  1. Home
  2. Cardiogenic Shock
  3. NCT03773822

Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. — COCCA  

Cardiogenic Shock Clinical Trial

Official title:
Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study

Clinical Trial 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.

Clinical Trial 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 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03773822
Study type Interventional
Source CMC Ambroise Paré
Contact
Status Completed
Phase Phase 3
Start date April 19, 2019
Completion date April 5, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03283995 - Hemodynamic Assessment in Cardiogenic Shock Regarding the Etiology
Active, not recruiting NCT04325035 - The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock Phase 2
Active, not recruiting NCT05100836 - SURPASS Impella 5.5 Study
Not yet recruiting NCT05106491 - Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients N/A
Completed NCT02301819 - ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock N/A
Completed NCT01367743 - Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock Phase 4
Recruiting NCT05728359 - Genomic Determinants of Outcome in Cardiogenic Shock
Recruiting NCT05699005 - Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO Phase 1
Not yet recruiting NCT06338345 - Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients N/A
Completed NCT03436641 - Microcirculation in Cardiogenic Shock
Recruiting NCT03313687 - SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK
Recruiting NCT05506449 - The RECOVER IV Trial N/A
Completed NCT04144660 - "Treatment Use of ECMO In Pregnancy or Peripartum Patient."
Completed NCT04548739 - Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
Recruiting NCT04141410 - Global Longitudinal Strain Assessment in Cardiogenic Shock During Sepsis
Not yet recruiting NCT05879276 - Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function. Phase 3
Enrolling by invitation NCT05570864 - Score TO Predict SHOCK - STOP SHOCK
Completed NCT02591771 - Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock Phase 2
Terminated NCT02279979 - Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial N/A
Completed NCT01374867 - CardShock Study and Registry N/A