HPA (stress hormone) function in adults who develop vasoplegia after cardiac surgery
Evaluation of the Hypothalamic-pituitary-adrenal Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery
This project will test whether the body's stress-hormone system (the HPA axis and cortisol response) is altered in adults who develop vasoplegic syndrome after heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06371976 on ClinicalTrials.gov |
What this trial studies
This is an observational study recruiting adults scheduled for cardiac surgery with extracorporeal circulation to collect blood samples and clinical data if they develop early post-operative vasoplegic syndrome. Investigators will measure cortisol and related HPA-axis markers, using stimulation testing (cosyntropin/ACTH) and modern assays such as tandem mass spectrometry where available, and record short-term vital status. The aim is to compare total and free cortisol dynamics and identify instances of relative adrenal insufficiency (CIRCI) in this specific post-cardiac surgery population. Patients with recent interfering medications or known pituitary/adrenal disease are excluded to avoid confounding of hormonal measurements.
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled for cardiac surgery with extracorporeal circulation, can give informed consent (or have a representative do so), and do not have recent interfering medications or known HPA-axis disease are ideal candidates.
Not a fit: People who recently received glucocorticoids or certain interacting drugs, those with known adrenal or pituitary pathology, cardiac transplant recipients, or patients requiring post-operative mechanical extracorporeal support are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify adrenal dysfunction in vasoplegia and better target corticosteroid use or other therapies for these patients.
How similar studies have performed: Similar hormone-measurement approaches have been applied in septic shock with mixed results and questions about cosyntropin testing, while direct study of HPA function specifically in post-cardiac surgery vasoplegia is largely unstudied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Paris, Île-de-France Region
- Pitié-Salpêtrière — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Adrien Bouglé, MD, PhD
- Email: adrien.bougle@aphp.fr
- Phone: 00 33 42 16 29 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.