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

NCT ID: NCT06371976

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2027-02-05

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).

Detailed Description

Vasoplegic syndrome after cardiac surgery is common (incidence 5-44%) and is associated with increased morbidity and mortality. It is characterized by early (immediately or within the first 24 hours post-operatively) and prolonged (more than 4 hours) 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) 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. An increase in the volume of cortisol distribution, a decrease in cortisol-binding protein and cortisol clearance (notably via an increase in bile acids) could distort test interpretation: the slight increase in total plasma cortisol would contrast with a normal increase in free cortisol.

Tandem mass spectrometry (LC-MS/MS) assays can be used to measure steroid metabolites (steroidome), enabling more precise exploration of the corticotropic axis. Another study, has shown that steroidome analysis by LC-MS/MS enables the diagnosis of adrenal insufficiency with excellent sensitivity and specificity in a population of women with hyperandrogenism.

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.

Conditions

Vasoplegic Syndrome in Adult Cardiac Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing cardiac surgery

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

Blood sampling

Intervention Type: 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.

Vital status

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pitié-Salpêtrière

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Adrien Bouglé, MD, PhD

Role: CONTACT

adrien.bougle@aphp.fr

00 33 42 16 29 91

Jérémie Guillemin, MD

Role: CONTACT

jeremie.guillemin@aphp.fr

00 33 84 82 82 58

Facility Contacts

Adrien Bouglé, MD, PhD

Role: primary

adrien.bougle@aphp.fr

00 33 42 16 29 91

Jérémie Guillemin, MD

Role: backup

jeremie.guillemin@aphp.fr

00 33 84 82 82 58

Other Identifiers

APH240230

Identifier Type: -

Identifier Source: org_study_id