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NCT Number: NCT06371976

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 4 hours post-operatively

    steroidome mapping (LC-MS/MS)

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: up to 28 days

    Number of days without catecholamines at day 28

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

    Time frame: up to 28 days

    Length of stay in critical care

  5. Evaluate the association between ""CIRCI"" and in-hospital mortality

    Time frame: up to 28 days

    mortality at day28

Study contacts

Contact information is provided by the study sponsor or research team.

Adrien Bouglé, MD, PhD

CONTACT

[email protected]

00 33 42 16 29 91

Jérémie Guillemin, MD

CONTACT

[email protected]

00 33 84 82 82 58

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Evaluation of the Hypothalamic-pituitary-adrenal Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery

Acronym: VASOCORT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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