NCT06371976 Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery
| NCT ID | NCT06371976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Vasoplegic Syndrome in Adult Cardiac Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-03-05 |
| Primary Completion | 2027-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-03-05 with a primary completion date of 2027-02-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06371976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vasoplegic Syndrome in Adult Cardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06371976 currently recruiting?
Yes, NCT06371976 is actively recruiting participants. Contact the research team at adrien.bougle@aphp.fr for enrollment information.
Where is the NCT06371976 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06371976 clinical trial?
NCT06371976 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 200 participants.