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

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ClinicalTrials.gov Identifier: NCT03773822
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
CMC Ambroise Paré

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 shock.

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Combination Product: Hydrocortisone + Flucortac Other: Placebo Phase 3

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study
Actual Study Start Date : April 19, 2019
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : July 20, 2021


Arm Intervention/treatment
Placebo Comparator: Placebo of hydrocortisone and placebo of fludrocortisone
Placebo of hydrocortisone as an iv bolus every 6 hours for seven days plus placebo of enteral fludrocortisone given once a day for seven days
Other: Placebo
Placebo

Experimental: Combination of hydrocortisone + fludrocortisone
Hydrocortisone will be given as 50 mg iv bolus every 6 hours for seven days and a tablet of 50 µg of fludrocortisone will be given once a day enterally for seven days
Combination Product: Hydrocortisone + Flucortac
Low dose steroids




Primary Outcome Measures :
  1. Patients not treated with corticosteroids at day 7 [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Mortality at 28 and 90 days after randomisation [ Time Frame: 28 and 90 days after randomisation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1- Cardiogenic shock state, according to the consensual definition 2. Having received informed information about the study and having signed a consent to participate in the study 3. Benefiting from a social security

Exclusion Criteria:

  1. Cardiogenic shock state with catecholamine infusion for more than 24 hours;
  2. Presence Presence of septic shock at inclusion;
  3. Cardiopulmonary arrest recovered within days (7 days) prior to inclusion;
  4. Patients already on circulatory support (ECMO) before inclusion (patients who are assisted after inclusion will not be excluded);
  5. Cardiogenic shock on viral myocarditis;
  6. Corticotherapy in the 4 weeks prior to inclusion;
  7. Receiving one of the following treatments: ketoconazole, rifampicin, phenytoin, phenobarbital, cyclosporine and clarithromycin;
  8. Known history of hypersensitivity to fludrocortisone or hydrocortisone;
  9. Known pregnancy or breastfeeding;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773822


Contacts
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Contact: Armand MEKONTSO DESSAP, MD (+33)1 46 25 24 33 armand.dessap@aphp.fr
Contact: François BAGATE,, MD (+33)1 49 81 23 89 francois.bagate@aphp.fr

Locations
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France
Hôpital Henri Mondor Recruiting
Paris, Ile De France, France
Contact: Armand MEKONTSO DESSAP, MD         
Principal Investigator: Armand MEKONTSO DESSAP, MD         
Sub-Investigator: François BAGATE, MD         
CMC Ambroise Paré Recruiting
Neuilly sur seine, France, 92200
Contact: Pierre SQUARA, MD    0146415079    recherche@clinique-a-pare.fr   
Contact: Messaouda MERZOUG, PhD       recherche@clinique-a-pare.fr   
Principal Investigator: Pierre SQUARA, MD         
Sub-Investigator: Philippe ESTAGNASIE, MD         
Sub-Investigator: Alain BRUSSET, MD         
Sub-Investigator: Driss LAGHLEM, MD         
Sponsors and Collaborators
CMC Ambroise Paré

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Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT03773822     History of Changes
Other Study ID Numbers: 2018/05
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CMC Ambroise Paré:
Cardiogenic Shock
Steroids
Hydrocortisone
Fludrocortisone
Reversal of shock
Mortality
Adrenal insufficiency
Additional relevant MeSH terms:
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Myocardial Ischemia
Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Fludrocortisone
Anti-Inflammatory Agents