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

NCT06371976 | Recruiting

• 1 other identifier: APH240230
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Vasoplegic Syndrome in Adult Cardiac Surgery

Keywords

vasoplegia; vasoplegic shock; cardiac vasoplegia syndrome

Outcome Measures

Primary Outcomes (1)

• Impact of post-cardiac surgery vasoplegic syndrome on corticotropic function.

  steroidome mapping (LC-MS/MS)

  4 hours post-operatively

Secondary Outcomes (5)

• Evaluate corticotropic function by measuring steroid metabolites according to the presence or absence of ""CIRCI"" in patients with vasoplegic syndrome.

  between day 0 and day 4

• Evaluate the association between CIRCI and the severity of vasoplegic syndrome after cardiac surgery.

  up to 28 days

• To assess the association between ""CIRCI"" and the duration of post-cardiac surgery vasoplegic syndrome.

  up to 28 days

• To assess the association between ""CIRCI"" and length of stay in intensive care.

  up to 28 days

• Evaluate the association between ""CIRCI"" and in-hospital mortality

  up to 28 days

Study Arms (1)

Patients undergoing cardiac surgery

The patients included will be adult patients scheduled for cardiac surgery with extracorporeal circulation.

Other: Blood sampling; Other: Vital status

Interventions

Blood sampling OTHER

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.

Patients undergoing cardiac surgery

Vital status OTHER

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.

Patients undergoing cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included will be adult patients scheduled for cardiac surgery with extracorporeal circulation.

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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié-Salpêtrière

Paris, Île-de-France Region, 75013, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Vasoplegia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Adrien Bouglé, MD, PhD

CONTACT

00 33 42 16 29 91; adrien.bougle@aphp.fr

Jérémie Guillemin, MD

CONTACT

00 33 84 82 82 58; jeremie.guillemin@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 17, 2024
• Study Start: March 5, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)