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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Impact of post-cardiac surgery vasoplegic syndrome on corticotropic function. [Срок оценки: 4 hours post-operatively]

Вторичные конечные точки (5)

• Evaluate corticotropic function by measuring steroid metabolites according to the presence or absence of ""CIRCI"" in patients with vasoplegic syndrome. [Срок оценки: between day 0 and day 4]
• Evaluate the association between CIRCI and the severity of vasoplegic syndrome after cardiac surgery. [Срок оценки: up to 28 days]
• To assess the association between ""CIRCI"" and the duration of post-cardiac surgery vasoplegic syndrome. [Срок оценки: up to 28 days]
• To assess the association between ""CIRCI"" and length of stay in intensive care. [Срок оценки: up to 28 days]
• Evaluate the association between ""CIRCI"" and in-hospital mortality [Срок оценки: up to 28 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Pitié-Salpêtrière — Paris

Идентификаторы

NCT: NCT06371976 · APH240230

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗