Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-01
Brief Title:
Shock and Acute Conditions OutcOmes Platform
Sponsor:
Saint-Louis Hospital Paris France
Organization:
Saint-Louis Hospital Paris France
Study Overview
Official Title:
Beyond the Syndromic Approach in Critical Care Identifying Biomarker-driven Subphenotypes of Circulatory Shock
Status:
ACTIVE_NOT_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:
ShockCO-OP
Brief Summary:
In-hospital mortality of patients admitted in the intensive care unit ICU for circulatory shock remains high between 20 and 40
Currently there are no markers that allow us to classify patients with circulatory shock at higher risk of early and late bad outcomes or who may better respond to a specific intervention
To understand the contribution of biological heterogeneity to circulatory shock independently from its etiology the ShockCO-OP Research Program aims to use clustering approaches to re-analyze existing clinical and molecular data from several large European and North American prospective cohorts and clinical trials
This will enable an improvement in risk prediction and a better patient selection in future clinical trials to assess a personalized therapy ie prospective enrollment based on a biologicalmolecular signature
Currently there are no markers that allow us to classify patients with circulatory shock at higher risk of early and late bad outcomes or who may better respond to a specific intervention
To understand the contribution of biological heterogeneity to circulatory shock independently from its etiology the ShockCO-OP Research Program aims to use clustering approaches to re-analyze existing clinical and molecular data from several large European and North American prospective cohorts and clinical trials
This will enable an improvement in risk prediction and a better patient selection in future clinical trials to assess a personalized therapy ie prospective enrollment based on a biologicalmolecular signature
Detailed Description:
Traditionally circulatory shock subgroups are defined according to hemodynamic profile eg hypovolemic distributive cardiogenic and etiology eg trauma infection myocardial infarction among others and are incorrectly considered as homogeneous clinical syndromes Emerging translational evidence highlights the existing molecular heterogeneity in the circulatory shock syndrome Such findings raise a major issue in assessing neutral clinical trial results in circulatory shock as a given intervention effect eg fluid management vasopressorsinotropes mechanical circulatory support may preferentially impact different subgroups ie heterogeneity of treatment effect
Accordingly identifying distinct biological subphenotypes with different mechanistic signatures may provide new insights regarding the pathophysiology of circulatory shock This may allow predictive enrichment ie identifying those patients most likely to benefit from a particular therapy and biomarker-driven or phenotype-driven patient selection in future clinical trials to assess a personalized therapy ie prospective enrollment based on a biological signature
The ShockCO-OP Research Program aims to use unsupervised model-based clustering ie regardless of outcome to reanalyze existing clinical and biological data in several European and North American prospective cohorts and clinical trials to identify distinct biomarker-driven subphenotypes in circulatory shock syndromes their underlying molecular signatures proteomics transcriptomics their association with outcome and their response to different interventions
Accordingly identifying distinct biological subphenotypes with different mechanistic signatures may provide new insights regarding the pathophysiology of circulatory shock This may allow predictive enrichment ie identifying those patients most likely to benefit from a particular therapy and biomarker-driven or phenotype-driven patient selection in future clinical trials to assess a personalized therapy ie prospective enrollment based on a biological signature
The ShockCO-OP Research Program aims to use unsupervised model-based clustering ie regardless of outcome to reanalyze existing clinical and biological data in several European and North American prospective cohorts and clinical trials to identify distinct biomarker-driven subphenotypes in circulatory shock syndromes their underlying molecular signatures proteomics transcriptomics their association with outcome and their response to different interventions
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