Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock.

NCT03773822 | Completed Phase 3

• 1 other identifier: 2018/05
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 21

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.

Conditions

Cardiogenic Shock

Keywords

Cardiogenic Shock; Steroids; Hydrocortisone; Fludrocortisone; Reversal of shock; Mortality; Adrenal insufficiency

Outcome Measures

Primary Outcomes (1)

• Patients not treated with corticosteroids at day 7

  7 days

Secondary Outcomes (11)

• Mortality at 28 and 90 days after randomisation

  28 and 90 days after randomisation

• Modification of the cardiac index

  7 days

• Length of stay in intensive care and hospital

  28 and 90 days after randomisation

• Duration of support by catecholamines

  28 days after randomisation

• Clearance of lactatemia

  7 days

Study Arms (2)

Placebo of hydrocortisone and placebo of fludrocortisone

PLACEBO COMPARATOR

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

Combination of hydrocortisone + fludrocortisone

EXPERIMENTAL

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

Interventions

Hydrocortisone + Flucortac COMBINATION_PRODUCT

Low dose steroids

Combination of hydrocortisone + fludrocortisone

Placebo OTHER

Placebo

Placebo of hydrocortisone and placebo of fludrocortisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiogenic shock state with catecholamine infusion for more than 24 hours;
• 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;

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (21)

Hôpital Parly II

Le Chesnay, Le Chasnay, 78150, France

Location

CH Intercommunal de Villeneuve Saint Georges

Villeneuve-Saint-Georges, Villeneuve Saint Georges, 94190, France

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

CH de Marne la Vallée - Site Jossigny

Jossigny, 77600, France

Location

CHU Lille - Institut Cœur Poumon

Lille, 59000, France

Location

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69007, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

Hôpital Arnaud-de-Villeneuve

Montpellier, 34090, France

Location

CMC Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

Hôpitaux Universitaires Pitié Salpêtrière

Paris, 75013, France

Location

Groupe Hospitalier Paris Saint Joseph

Paris, 75014, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital européen Georges-Pompidou

Paris, 75015, France

Location

Hôpital Bichat

Paris, 75018, France

Location

CH Pontoise

Pontoise, 95300, France

Location

Centre cardiologique du nord saint denis

Saint-Denis, 93200, France

Location

CHU de Strasbourg

Strasbourg, 67000, France

Location

Hopital Rangueil

Toulouse, 31400, France

Location

CHRU Hôpitaux de Tours

Tours, 37000, France

Location

Hôpital Henri Mondor

Paris, Île-de-France Region, France

Location

Related Publications (1)

• Mekontso Dessap A, Bagate F, Delmas C, Morichau-Beauchant T, Cholley B, Cariou A, Lattuca B, Moussa M, Mongardon N, Fard D, Schmidt M, Bougle A, Kerneis M, Vivier E, Roubille F, Duprey M, Decalf V, Genet T, Merzoug M, Audureau E, Squara P. Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial. Trials. 2022 Jan 3;23(1):4. doi: 10.1186/s13063-021-05947-6.

  PMID: 34980224 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic; Adrenal Insufficiency

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 12, 2018
• Study Start: April 19, 2019
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

FR (21)