Cardiogenic ShockPhase 3COCCANCT03773822
Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock.
A Phase 3 study testing Hydrocortisone + Flucortac in people with Cardiogenic Shock, run by CMC Ambroise Paré at 21 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Hydrocortisone + Flucortac
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 21 sitesFrance
- Study dates
- 19 Apr 2019to 5 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiogenic shock state with catecholamine infusion for more than 24 hours;
- Presence Presence of septic shock at inclusion;
- Cardiopulmonary arrest recovered in the 7 days preceding inclusion with at least one early sign of poor prognosis among the following: no control, non-shockable rhythm, CAHP score (Cardiac Arrest Hospital Prognosis)> 150;
- Patients already on circulatory support (ECMO) before inclusion (patients who are assisted after inclusion will not be excluded);
- Cardiogenic shock on viral myocarditis;
- Prior corticosteroid therapy (≥ 30 mg prednisone or equivalent ≥ 1 month);
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- 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;
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Hôpital Ambroise Paré
Boulogne-Billancourt, Boulogne-Billancourt, 92100
CH de Marne la Vallée - Site Jossigny
Jossigny, Jossigny, 77600
Hôpital Parly II
Le Chesnay, Le Chasnay, 78150
CHU Lille - Institut Cœur Poumon
Lille, 59000
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
Hôpital Privé Jacques Cartier
Massy, Massy, 91300
Hôpital Arnaud-de-Villeneuve
Montpellier, 34090
CMC Ambroise Paré
Neuilly-sur-Seine, 92200
CHU de Nîmes
Nîmes, 30029
Hôpitaux Universitaires Pitié Salpêtrière
Paris, 75013
Groupe Hospitalier Paris Saint Joseph
Paris, 75014
Hôpital Cochin
Paris, 75014
Hôpital européen Georges-Pompidou
Paris, 75015
Hôpital Bichat
Paris, 75018
Hôpital Henri Mondor
Paris, Île-de-France Region
CH Pontoise
Pontoise, 95300
Centre cardiologique du nord saint denis
Saint-Denis, 93200
CHU de Strasbourg
Strasbourg, Strasbourg, 67000
Hopital Rangueil
Toulouse, 31400
CHRU Hôpitaux de Tours
Tours, 37000
CH Intercommunal de Villeneuve Saint Georges
Villeneuve-Saint-Georges, Villeneuve Saint Georges, 94190
About this study
Official title: Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study
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.
Read the 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.
- Conditions
- Cardiogenic Shock
- Being tested
- Hydrocortisone + Flucortac, Placebo
- Keywords
- Cardiogenic Shock, Steroids, Hydrocortisone, Fludrocortisone, Reversal of shock, Mortality, Adrenal insufficiency
- Medical subject headings
- Shock, Cardiogenic, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone + FlucortacCombination product
Low dose steroids
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Combination Product: Hydrocortisone + Flucortac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days alive and free of catecholamine support through day 7
Measured: 7 days
Secondary outcomes (11)
Mortality at 28 and 90 days after randomisation
Measured: 28 and 90 days after randomisation
Modification of the cardiac index
Measured: 7 days
Length of stay in intensive care and hospital
Measured: 28 and 90 days after randomisation
Duration of support by catecholamines
Measured: 28 days after randomisation
Clearance of lactatemia
Measured: 7 days
Number of patients use of mechanical ventilation
Measured: 28 days after randomisation
Number of patients with Circulatory assistance
Measured: 28 days after randomisation
Number of patients alive at day 7 without failure (SOFA) score)
Measured: 7 days
Rate of patients with nosocomial infection
Measured: 28 days after randomisation
Rates of patients requiring the introduction of intravenous insulin therapy after randomization
Measured: 7 days
Modification of mean arterial pressure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start19 Apr 2019
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773822
- Sponsor's protocol ID
- 2018/05
- Acronym
- COCCA
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2018
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34980224
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03773822
- Acronym / sponsor ID
- COCCA / 2018/05
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic Shock, Steroids, Hydrocortisone, Fludrocortisone, Reversal of shock, Mortality, Adrenal insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo of hydrocortisone and placebo of fludrocortisone | Placebo comparator | Other: PlaceboPlacebo of hydrocortisone as an iv bolus every 6 hours for seven days plus placebo of enteral fludrocortisone given once a day for seven days |
| Combination of hydrocortisone + fludrocortisone | Experimental | Combination Product: Hydrocortisone + FlucortacHydrocortisone 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18 years
- Cardiogenic shock state, according to the consensual definition:
- Having received informed information about the study and having signed a consent to participate in the study
- Benefiting from a social security
Key exclusion criteria (9 listed)
- Cardiogenic shock state with catecholamine infusion for more than 24 hours;
- Presence Presence of septic shock at inclusion;
- Cardiopulmonary arrest recovered in the 7 days preceding inclusion with at least one early sign of poor prognosis among the following: no control, non-shockable rhythm, CAHP score (Cardiac Arrest Hospital Prognosis)> 150;
- Patients already on circulatory support (ECMO) before inclusion (patients who are assisted after inclusion will not be excluded);
- Cardiogenic shock on viral myocarditis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone + FlucortacLow dose steroids | Combination product | Combination of hydrocortisone + fludrocortisone |
| PlaceboPlacebo | Other | Placebo of hydrocortisone and placebo of fludrocortisone |
Primary outcome
Number of days alive and free of catecholamine support through day 7
Time frame: 7 days
11 secondary outcomes
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
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 34980224Mekontso 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone + Flucortac in people with Cardiogenic Shock, run by CMC Ambroise Paré at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days alive and free of catecholamine support through day 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.