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Clinical Trials in France / NCT06371976
Recruiting Observational

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

NCT06371976 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2025-03-05
Last updated
2026-01-30

Condition(s) studied

Vasoplegic Syndrome in Adult Cardiac Surgery

Investigational drug(s) / intervention(s)

Blood samplingVital status

Blood sampling: Blood samples of 5 mL are taken at 4 stages of the study. Samples are taken from an arterial catheter inserted as part of the treatment, for a total volume of 20 mL maximum for the study.

Vital status: Patients will be followed until their discharge from intensive care, or at most until D28, and their vital status will be collected at the end of their participation in the study.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Impact of post-cardiac surgery vasoplegic syndrome on corticotropic function. — 4 hours post-operatively
    steroidome mapping (LC-MS/MS)

Trial sites (1)

FacilityCityRegionStatus
Pitié-Salpêtrière Paris Île-de-France Region Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06371976 on ClinicalTrials.gov ↗ ← All trials in France