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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

Qualifiers

Age > 18 years.

Patient at intermediate/high risk (EuroSCORE II > 4%).

Coronary artery bypass grafting (CABG).

Aortic valve replacement.

Disqualifiers

Endocarditis

Off-pump heart surgery

Heart transplantation or long-term ventricular assist device (VAD)

Emergency surgery: aortic dissection, emergency coronary artery bypass grafting (CABG)

Trial design

Treatments tested in this trial

  • hydrocortisone plus fludrocortisone
  • placebo of hydrocortisone plus fludrocortisone

Treatment groups

196 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Universitaire, Amiens

Lead sponsor

University Hospital, Rouen

Collaborator

University Hospital, Lille

Collaborator