Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318689
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-23
Brief Title:
In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Vaso-shock
Brief Summary:
The goal of this observational study is to assess in situ vascular function glycocalyx and microcirculation in postoperative vasoplegic shock following cardiac surgery with cardiopulmonary bypass
The main question is to investigate the relationship between NO-dependent vasomotor reserve and the presence of vasoplegic shock following cardiac surgery with cardiopulmonary bypass
Participants will have two visits during which a number of non-invasive examinations will be carried out to study glycocalyx microcirculation and vascular function Biological and morphological data will be collected up to 3 months after inclusion as well as information on treatments administered and outcome
Researchers will compare a group of patients with vasoplegic shock against a group without vasoplegic shock in order to study possible alterations in function in the vasoplegic shock group
The main question is to investigate the relationship between NO-dependent vasomotor reserve and the presence of vasoplegic shock following cardiac surgery with cardiopulmonary bypass
Participants will have two visits during which a number of non-invasive examinations will be carried out to study glycocalyx microcirculation and vascular function Biological and morphological data will be collected up to 3 months after inclusion as well as information on treatments administered and outcome
Researchers will compare a group of patients with vasoplegic shock against a group without vasoplegic shock in order to study possible alterations in function in the vasoplegic shock group
Detailed Description:
Objective the primary objective of this study is to explore in situ the glycocalyx the microcirculation and vascular function in postoperative vasoplegic shock following cardiac surgery with CPB Secondary objectives are to study links between vascular function and damage to the glycocalyx and microcirculation and patient prognosis in particular their impact on fluid balance
Method
Constitution of a single-centre prospective cohort study of 124 patients Patients hospitalised in the cardiac intensive care unit after cardiac surgery with CPB will be consecutively included from 4 to 24 hours after surgery 62 patients with vasoplegic shock noradrenaline 005µgkgmin for at least 4 hours and after correction of any hypovolaemia 62 patients without vasoplegic shock
Endothelial function will be assessed using the flow-mediated dilation FMD method to test brachial artery vasodilation mediated by nitric oxide NO after induced ischemia Microcirculation and glycocalyx will be evaluated using GlycoCheck providing several measurements of microcirculation and glycocalyx using Sidestream Dark Field technology mucosal illumination by a green LED and continuous x20 magnification video recording at the sublingual mucosa level Various endothelial and inflammatory markers will also be measured VCAM-1 syndecan endothelin interleukin-6
Each patient will be assessed at inclusion and 48 hours using GlycoCheck FMD and endothelial measurements then followed through their medical records for 90 days where a follow-up call will be conducted to assess outcomes Collected information will include routine care data morphological data vital signs laboratory tests fluid balance scores treatments surgical data
Both groups will be compared using statistical tests and risk factors for developing vasoplegic shock will be explored through logistic regression Univariable analysis followed by multivariable logistic regression with backward data inclusion will then be performed to identify risk factors for vasoplegic syndrome within the entire cohort necessarily including FMD and GlycoCheck A p-value 005 will be considered statistically significant
Method
Constitution of a single-centre prospective cohort study of 124 patients Patients hospitalised in the cardiac intensive care unit after cardiac surgery with CPB will be consecutively included from 4 to 24 hours after surgery 62 patients with vasoplegic shock noradrenaline 005µgkgmin for at least 4 hours and after correction of any hypovolaemia 62 patients without vasoplegic shock
Endothelial function will be assessed using the flow-mediated dilation FMD method to test brachial artery vasodilation mediated by nitric oxide NO after induced ischemia Microcirculation and glycocalyx will be evaluated using GlycoCheck providing several measurements of microcirculation and glycocalyx using Sidestream Dark Field technology mucosal illumination by a green LED and continuous x20 magnification video recording at the sublingual mucosa level Various endothelial and inflammatory markers will also be measured VCAM-1 syndecan endothelin interleukin-6
Each patient will be assessed at inclusion and 48 hours using GlycoCheck FMD and endothelial measurements then followed through their medical records for 90 days where a follow-up call will be conducted to assess outcomes Collected information will include routine care data morphological data vital signs laboratory tests fluid balance scores treatments surgical data
Both groups will be compared using statistical tests and risk factors for developing vasoplegic shock will be explored through logistic regression Univariable analysis followed by multivariable logistic regression with backward data inclusion will then be performed to identify risk factors for vasoplegic syndrome within the entire cohort necessarily including FMD and GlycoCheck A p-value 005 will be considered statistically significant
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