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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing cardiac surgery | The patients included will be adult patients scheduled for cardiac surgery with extracorporeal circulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of post-cardiac surgery vasoplegic syndrome on corticotropic function. | steroidome mapping (LC-MS/MS) | 4 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate corticotropic function by measuring steroid metabolites according to the presence or absence of ""CIRCI"" in patients with vasoplegic syndrome. | 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. | between day 0 and day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients included will be adult patients scheduled for cardiac surgery with extracorporeal circulation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrien Bouglé, MD, PhD | Contact | 00 33 42 16 29 91 | adrien.bougle@aphp.fr | |
| Jérémie Guillemin, MD | Contact | 00 33 84 82 82 58 | jeremie.guillemin@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié-Salpêtrière | Recruiting | Paris | Île-de-France Region | 75013 | France |
The procedures carried out with the French data privacy authority (CNIL, "Commission nationale de l'informatique et des libertés") do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D056987 | Vasoplegia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum
| 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. |
|
| Evaluate the association between CIRCI and the severity of vasoplegic syndrome after cardiac surgery. |
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 |
| up to 28 days |
| To assess the association between ""CIRCI"" and the duration of post-cardiac surgery vasoplegic syndrome. | Number of days without catecholamines at day 28 | up to 28 days |
| To assess the association between ""CIRCI"" and length of stay in intensive care. | Length of stay in critical care | up to 28 days |
| Evaluate the association between ""CIRCI"" and in-hospital mortality | mortality at day28 | up to 28 days |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |