Shock and Acute Conditions OutcOmes Platform
ShockCO-OP
Beyond the Syndromic Approach in Critical Care: Identifying Biomarker-driven Subphenotypes of Circulatory Shock
1 other identifier
observational
1,000
1 country
1
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 (i.e., prospective enrollment based on a biological/molecular signature).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
April 1, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedApril 19, 2024
April 1, 2024
1.5 years
April 1, 2024
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality rate
28 days
Secondary Outcomes (4)
Mortality rate
1 year
Renal replacement therapy use rate
28 days
Mechanical circulatory support use rate
28 days
Vasopressors and inotropes-free days
28 days
Interventions
Vasopressors: Norepinephrine, vasopressin Inotropes: Epinephrine, Dobutamine, Milrinone
Intra-aortic balloon pump Extracorporeal membrane oxygenation (ECMO)
Anti-Dipeptidyl peptidase 3 (DPP3), Anti-Bioactive adrenomedullin (bio-ADM)
Eligibility Criteria
Patients with circulatory shock on admission independently from its etiology
You may qualify if:
- Patients with circulatory shock on admission (i.e., the reported main cause of admission is septic shock, cardiogenic shock or hypovolemic/hemorrhagic shock).
- Patients who required vasopressors infusion and presented signs of tissue hypoperfusion (e.g., altered mental state (Glasgow coma scale≤ 14), oliguria (urine output of \< 0.5 ml/kg/h for at least six hours) or a serum lactate level of ≥2 mmol/l) within the first 24 h after admission.
You may not qualify if:
- Mechanical circulatory support on admission
- Serious arrythmia (e.g., rapid atrial fibrillation or ventricular tachycardia/fibrillation) on admission
- Deceased patients within the first 24 hours after admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Saint-Louis Hospital, Paris, Francelead
- University of Helsinkicollaborator
- University of Ottawacollaborator
- University of Leipzigcollaborator
- University of Nancycollaborator
- McGill Universitycollaborator
- Mayo Cliniccollaborator
- University of Paris 5 - Rene Descartescollaborator
- University of Torontocollaborator
Study Sites (1)
St Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Related Publications (5)
Soussi S, Dos Santos C, Jentzer JC, Mebazaa A, Gayat E, Poss J, Schaubroeck H, Billia F, Marshall JC, Lawler PR. Distinct host-response signatures in circulatory shock: a narrative review. Intensive Care Med Exp. 2023 Aug 18;11(1):50. doi: 10.1186/s40635-023-00531-5.
PMID: 37592121BACKGROUNDSarma D, Jentzer JC, Soussi S. Cardiogenic shock: a major challenge for the clinical trialist. Curr Opin Crit Care. 2023 Aug 1;29(4):371-380. doi: 10.1097/MCC.0000000000001066. Epub 2023 Jun 19.
PMID: 37338937BACKGROUNDMebazaa A, Soussi S. Precision Medicine in Cardiogenic Shock: We Are Almost There! JACC Heart Fail. 2023 Oct;11(10):1316-1319. doi: 10.1016/j.jchf.2023.06.024. Epub 2023 Aug 16. No abstract available.
PMID: 37589609BACKGROUNDSoussi S, Collins GS, Juni P, Mebazaa A, Gayat E, Le Manach Y. Evaluation of Biomarkers in Critical Care and Perioperative Medicine: A Clinician's Overview of Traditional Statistical Methods and Machine Learning Algorithms. Anesthesiology. 2021 Jan 1;134(1):15-25. doi: 10.1097/ALN.0000000000003600.
PMID: 33216849BACKGROUNDSoussi S, Tarvasmaki T, Kimmoun A, Ahmadiankalati M, Azibani F, Dos Santos CC, Duarte K, Gayat E, Jentzer JC, Harjola VP, Hibbert B, Jung C, Johan L, Levy B, Lu Z, Lawler PR, Marshall JC, Poss J, Sadoune M, Nguyen A, Raynor A, Peoc'h K, Thiele H, Mathew R, Mebazaa A. Identifying biomarker-driven subphenotypes of cardiogenic shock: analysis of prospective cohorts and randomized controlled trials. EClinicalMedicine. 2024 Dec 18;79:103013. doi: 10.1016/j.eclinm.2024.103013. eCollection 2025 Jan.
PMID: 39802301DERIVED
Biospecimen
Plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia dos Santos, MD, PhD
Unity Health Toronto
- STUDY CHAIR
Alexandre Mebazaa, MD, PhD
St Louis and Lariboisiere Hospitals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 1, 2024
First Posted
April 19, 2024
Study Start
January 1, 2024
Primary Completion
July 1, 2025
Study Completion
January 1, 2026
Last Updated
April 19, 2024
Record last verified: 2024-04