Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery

Recruiting now

Conditions studied: Vasoplegic Syndrome in Adult Cardiac Surgery

In brief

Vasoplegic syndrome after cardiac surgery is common and is associated with increased morbidity and mortality. It is characterized by early and prolonged arterial hypotension, with preserved cardiac output and low systemic vascular resistance. Vasoplegic syndrome therefore shares pathophysiological features with septic shock. There are no data in the literature on the function of the hypothalamic-pituitary-adrenal (HPA) axis during vasoplegic syndrome after cardiac surgery. In situations of acute stress and systemic inflammation, relative adrenal insufficiency has been reported in the most severe patients, particularly those in septic shock. The term ""CIRCI"" (Critical Illness-Related Corticosteroid Insufficiency) is currently defined as an increase in total plasma cortisol of less than 9 µg/dl after stimulation with 250 µg tetracosactide (synthetic ACTH), or a basal total plasma cortisol level of less than 10 µg/dl. However, recent studies have called into question the usefulness of the cosyntropin stimulation test for exploring the HPA axis in intensive care patients. Tandem mass spectrometry (LC-MS/MS) assays can be used to measure steroid metabolites (steroidome), enabling more precise exploration of the corticotropic axis. The aim of this study is to evaluate, on an exploratory basis, the impact of the presence of a post-cardiac surgery vasoplegic syndrome on adrenal function by steroidome mapping (LC-MS/MS).

Key facts

Study ID

NCT06371976

Run by

Assistance Publique - Hôpitaux de Paris

People needed

200

Starts

2025-03-05

Expected to finish

2027-02-05

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Scheduled cardiac surgery with extracorporeal circulation
• Patient or trusted person or legal representative informed and having expressed non-opposition to participation in the study.

You may not qualify if…

• Previous treatment within the last 3 months with glucocorticoids, azoles (Fluconazole, Voriconazole), phenytoin, rifampin, glitazones (Rosiglitazone or Pioglitazone), imipraminics (Clomipramine, Imipramine, Amitriptyline), barbiturates (Primidone, Phenobarbital, Thiopenthal) or phenothiazines (Chlorpromazine, Cyamemazine).
• Adrenal or intracranial pathology affecting the hypothalamic-pituitary axis.
• Cardiac transplants.
• Post-operative mechanical extracorporeal assistance.
• Patient deprived of liberty by judicial or administrative decision.

Where it is running

• Pitié-Salpêtrière — Paris, Île-de-France Region, France (enrolling)

Full record on ClinicalTrials.gov

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