Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hydrocortisone plus fludrocortisone, placebo of hydrocortisone plus fludrocortisone.
- Who it may be relevant to
- Registry conditions: Inflammation in Cardiac Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Cardiac surgery is a high-risk surgery and is associated with a rate of postoperative adverse outcomes. Like many others major surgery, cardiac surgery procedures induce a proinflammatory phase usually counterbalanced with an immunosuppressive phase so the immune response remained balanced. In some cases, the immune response might be dysregulated with a more pronounced pro inflammatory state that compromises organ perfusion and with the occurrence of organ failure. From a mechanistic approach, the relationship between organ failure is complex and multifactorial with a high level of proinflammatory cytokines, a decrease in microcirculation, an endothelial dysfunction and an activation of coagulation and over. The clinical expression is an increase in vasopressor exposure and dose, an increase in mortality and in adverse outcomes with a predominance of acute kidney injury. Various therapies have been assessed to manage cardiac surgery related sepsis including glucocorticoid therapy. Briefly, two major randomized trials assessed glucocorticoid therapy solely in scheduled cardiac surgery with cardiopulmonary bypass. No clinical benefit was demonstrated in term of reduction in postoperative mortality or adverse outcomes. Since, data support that the selection of patients at risk is crucial to demonstrate such a strategy. Indeed, data support that surprisingly some patients will have a very light immune response reflected by a low pro inflammatory cytokine. The hypothesis is that the combination glucocorticoid and fludrocortisone could decrease adverse outcomes in selected patients.
Interventions
- Drug hydrocortisone plus fludrocortisone
* Hydrocortisone 200 mg/day for 5 days or until ICU discharge, starting at the initiation of cardiopulmonary bypass (CPB), administered intravenously via syringe pump in a double-blind manner * Fludrocortisone 50 µg/day in the morning for 5 days or until ICU discharge, administered orally or via nasogastric tube (if the patient is sedated), diluted in a glass of water, in a double-blind manner - Drug placebo of hydrocortisone plus fludrocortisone
* Placebo for hydrocortisone (0.9% NaCl) administered following the same protocol as fludrocortisone in the intervention group * Placebo for fludrocortisone (capsule containing microcrystalline cellulose diluted in a glass of water) administered following the same protocol as fludrocortisone in the intervention group
Primary outcome measures
- Variation of acute kidney injury occurence between both groups [Time frame: up to 7 days]
- Variation of postoperative pulmonary complication occurrence between both groups [Time frame: up to 7 days]
- Variation of number of norepinephrine requirement between both groups [Time frame: up to 7 days]
Secondary outcome measures (6)
- variation of postoperative atrial fibrillation occurence between both groups [Time frame: up to 7 days]
- variation of myocardial infarction occurence between both groups [Time frame: up to 7 days]
- variation of stroke occurence between both groups [Time frame: up to 7 days]
- Variation of total amount of norepinephrine between both groups [Time frame: up to 7 days]
- variation of occurrence of glucocorticoid side effect between both groups [Time frame: up to 7 days]
- Variation of 28-day mortality between both groups [Time frame: at 28 days]
Eligibility criteria
Inclusion criteria
- Age > 18 years.
- Patient at intermediate/high risk (EuroSCORE II > 4%).
- Patient admitted for scheduled cardiac surgery:
- Coronary artery bypass grafting (CABG).
- Aortic valve replacement.
- Mitral valve repair or replacement.
- Surgery of the aortic root (aortic tube, Bentall procedure, Tirone David procedure, or other).
- Combined surgery.
- Patient undergoing cardiopulmonary bypass (CPB).
- Informed consent signed by the patient.
Exclusion criteria
- Endocarditis
- Off-pump heart surgery
- Heart transplantation or long-term ventricular assist device (VAD)
- Emergency surgery: aortic dissection, emergency coronary artery bypass grafting (CABG)
- Failure to wean from CPB requiring short-term mechanical support (intra-aortic balloon pump, ECMO)
- Hypothermic surgery
- History of cardiac surgery
- Patient on long-term corticosteroid therapy
- Autoimmune disease or chronic inflammatory condition
- End-stage renal disease on long-term dialysis
- Contraindications to the administration of hydrocortisone and/or fludrocortisone according to the summary of product characteristics (SmPC)
- Pregnant or breastfeeding woman
- Patient under legal protection (guardianship, curators, or judicial safeguard).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHRU Amiens — Amiens
Identifiers
NCT: NCT07037043 · PI2024_843_0047