Pitié-Salpêtrière
Paris, Île-de-France Region, 75013, France
Location status: Recruiting
Location contact
Adrien Bouglé, MD, PhD
CONTACT
Jérémie Guillemin, MD
CONTACT
NCT Number: NCT06371976
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, Île-de-France Region, 75013, France
Location status: Recruiting
Adrien Bouglé, MD, PhD
CONTACT
Jérémie Guillemin, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: 4 hours post-operatively
steroidome mapping (LC-MS/MS)
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.
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
Time frame: up to 28 days
Number of days without catecholamines at day 28
Time frame: up to 28 days
Length of stay in critical care
Time frame: up to 28 days
mortality at day28
Contact information is provided by the study sponsor or research team.
Adrien Bouglé, MD, PhD
CONTACT
Jérémie Guillemin, MD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Evaluation of the Hypothalamic-pituitary-adrenal Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery
Acronym: VASOCORT
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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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