Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371976
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-21
Brief Title:
Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of the Hypothalamic-pituitary-adrenal Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VASOCORT
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 µgdl after stimulation with 250 µg tetracosactide synthetic ACTH or a basal total plasma cortisol level of less than 10 µgdl 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-MSMS 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-MSMS
Tandem mass spectrometry LC-MSMS 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-MSMS
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 µgdl after stimulation with 250 µg tetracosactide synthetic ACTH or a basal total plasma cortisol level of less than 10 µgdl 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-MSMS 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-MSMS 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
Tandem mass spectrometry LC-MSMS 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-MSMS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None