HPA (stress hormone) function in adults who develop vasoplegia after cardiac surgery
Official title: Evaluation of the Hypothalamic-pituitary-adrenal Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery
Run by Assistance Publique - Hôpitaux de Paris · NCT06371976 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Status | Recruiting |
| Started | March 5, 2025 |
| Main results expected | February 5, 2027 |
| Study ends | February 5, 2027 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT06371976 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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We will test whether adding earlobe and palm skin sensors plus clinical and blood measurements during and for 48 hours after heart surgery helps understand and predict vasoplegic syndrome in patients at higher risk.
-
Comparing vasopressin and norepinephrine for treating low blood pressure after heart surgery
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.