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

Not yet recruiting

• Conditions: Vasoplegic Syndrome in Adult Cardiac Surgery
• Interventions: Other: Blood sampling; Other: Vital status

• Registration Number: NCT06371976
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2024-03-21
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17
• Study Start: 2024-06-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing cardiac surgery	Blood sampling	The patients included will be adult patients scheduled for cardiac surgery with extracorporeal circulation.
Patients undergoing cardiac surgery	Vital status	The patients included will be adult patients scheduled for cardiac surgery with extracorporeal circulation.

Primary Outcome Measures

Name	Time	Method
Impact of post-cardiac surgery vasoplegic syndrome on corticotropic function.	4 hours post-operatively	steroidome mapping (LC-MS/MS)

Secondary Outcome Measures

Name	Time	Method
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	increase in total plasma cortisol below 9 µg/dl after stimulation with 250 µg IV tetracosactide (synthetic ACTH) or basal total plasma cortisol below 10 µg/dl.
Evaluate the association between CIRCI and the severity of vasoplegic syndrome after cardiac surgery.	up to 28 days	duration of catecholamine support, maximum vaso-inotropic score in the first 24 hours (VISmaxH24), variation in the Sequential Organ Failure score (ΔH48-SOFA) over the first 48 hours, duration of mechanical ventilation, duration of extra-renal purification, D28 mortality
To assess the association between ""CIRCI"" and the duration of post-cardiac surgery vasoplegic syndrome.	up to 28 days	Number of days without catecholamines at day 28
To assess the association between ""CIRCI"" and length of stay in intensive care.	up to 28 days	Length of stay in critical care
Evaluate the association between ""CIRCI"" and in-hospital mortality	up to 28 days	mortality at day28

Trial Locations

Locations (1)

Pitié-Salpêtrière; 🇫🇷 Paris, Ile-de-France, France