Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. (NCT03773822) | Clinical Trial Compass
CompletedPhase 3
Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock.
France380 participantsStarted 2019-04-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested low-dose hydrocortisone and fludrocortisone specifically for cardiogenic shock — does my situation match the type of cardiogenic shock that was studied, and would those results even apply to me?
2Since this was a Phase 3 trial and it has already completed, has my doctor seen the published results, and do those results suggest any real-world benefit in reducing the days patients needed vasopressor or inotrope support?
3The trial measured 'days alive and free of catecholamine support' over 7 days — what does that outcome actually mean for longer-term survival or heart recovery, and should I be asking about those bigger-picture results too?
4Are there any safety concerns that came up with using low-dose corticosteroids like hydrocortisone and fludrocortisone in cardiogenic shock patients that my doctor thinks I should know about before considering this approach?
5Given that this trial is now completed, is the combination of hydrocortisone and fludrocortisone something doctors are actually using in practice for cardiogenic shock, or is standard care still the better first path for someone in my position?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of days alive and free of catecholamine support through day 7
. 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);