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NCT Number: NCT07037043

Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery

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.

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Key information

Conditions

Inflammation in Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Christophe Beyls, MD

CONTACT

[email protected]

33+3 22 08 78 66

Emmanuel Besnier, MD

PRINCIPAL_INVESTIGATOR

Mouhamed Djahoum MOUSSA, MD

PRINCIPAL_INVESTIGATOR

Osama Abou Arab, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

hydrocortisone plus fludrocortisone

Drug
  • 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

placebo of hydrocortisone plus fludrocortisone

Drug
  • 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 outcomes

  1. Variation of acute kidney injury occurence between both groups

    Time frame: up to 7 days

  2. Variation of postoperative pulmonary complication occurrence between both groups

    Time frame: up to 7 days

  3. Variation of number of norepinephrine requirement between both groups

    Time frame: up to 7 days

Secondary outcomes

  1. variation of postoperative atrial fibrillation occurence between both groups

    Time frame: up to 7 days

    Postoperative atrial fibrillation: defined as a new-onset arrhythmia within 7 days after surgery, documented by an electrocardiogram showing absence of P waves and narrow, irregular QRS complexes

  2. variation of myocardial infarction occurence between both groups

    Time frame: up to 7 days

    Myocardial infarction: defined according to the Fourth Universal Definition

  3. variation of stroke occurence between both groups

    Time frame: up to 7 days

    Stroke: defined as the sudden onset of a neurological deficit confirmed by brain imaging

  4. Variation of total amount of norepinephrine between both groups

    Time frame: up to 7 days

    The total amount of norepinephrine will be expressed in milligrams and will correspond to the cumulative dose administered from ICU admission until the 7th postoperative day.

  5. variation of occurrence of glucocorticoid side effect between both groups

    Time frame: up to 7 days

    glucocorticoid side effects are hyperglycemia, hypernatremia and infections

  6. Variation of 28-day mortality between both groups

    Time frame: at 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Beyls, MD

CONTACT

[email protected]

(33)3 22 08 78 66

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • University Hospital, Lille
  • University Hospital, Rouen

Registry information

Acronym: VASOCORT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 25, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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