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Active, not recruitingNCT06376318ShockCO-OPUpdated Apr 19, 2024

Shock and Acute Conditions OutcOmes Platform

An observational study in Circulatory Shock, Sepsis and Cardiogenic Shock, sponsored by Saint-Louis Hospital, Paris, France. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Saint-Louis Hospital, Paris, France · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 35 studies in Shock with a site in Canada — 9 open to participants now, 10 under way, 1 of them phase 3. Shock · Canada.

Planned enrollment
Largest of 11
1,000 · median 100
Started
2024
with 2 others
Observational
11 of 35
4 open now
Registered
32nd of 35
by date

Among the 35 studies in Shock with a site in Canada, this one has the largest planned enrollment of the 11 observational ones that give a count, is one of 3 that started in 2024, is one of 11 observational ones, and was the 32nd registered.

Shock

487 studies on the registry are indexed under Shock; 107 are open to participants now.

Browse Shock studies →

Open to participants now

9 of the 35 studies in Shock with a site in Canada are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 68 Shock studies recruiting now, 52 (76%) set no upper age limit and 11 (16%) stop at 75 or younger; 9 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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).

Read the detailed description

Traditionally, circulatory shock subgroups are defined according to hemodynamic profile (e.g., hypovolemic, distributive, cardiogenic) and etiology (e.g., 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 (e.g., fluid management, vasopressors/inotropes, mechanical circulatory support) may preferentially impact different subgroups (i.e., 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 (i.e., 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 (i.e., prospective enrollment based on a biological signature).

The ShockCO-OP Research Program aims to use unsupervised model-based clustering (i.e., 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.

03

Conditions studied

  • Circulatory Shock
  • Sepsis
  • Cardiogenic Shock
  • Major Trauma
  • Surgical Shock

Keywords

  • shock
  • heterogeneity of treatment effect
  • biomarkers
  • machine learning
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with circulatory shock on admission independently from its etiology

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with circulatory shock on admission (i.e., the reported main cause of admission is septic shock, cardiogenic shock or hypovolemic/hemorrhagic shock).
  2. 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.

Exclusion criteria

Exclusion Criteria:

  1. Mechanical circulatory support on admission
  2. Serious arrythmia (e.g., rapid atrial fibrillation or ventricular tachycardia/fibrillation) on admission
  3. Deceased patients within the first 24 hours after admission.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • DrugInotrope

    Vasopressors: Norepinephrine, vasopressin Inotropes: Epinephrine, Dobutamine, Milrinone

    Also known as: Vasopressor

  • DeviceMechanical circulatory support

    Intra-aortic balloon pump Extracorporeal membrane oxygenation (ECMO)

  • Anti-Dipeptidyl peptidase 3 (DPP3), Anti-Bioactive adrenomedullin (bio-ADM)

06

What researchers measure

Primary outcomes

  1. Mortality rate

    Time frame: 28 days

Secondary outcomes

  1. Mortality rate

    Time frame: 1 year

  2. Renal replacement therapy use rate

    Time frame: 28 days

  3. Mechanical circulatory support use rate

    Time frame: 28 days

  4. Vasopressors and inotropes-free days

    Time frame: 28 days

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 37592121 ↗
  • Sarma 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. PubMed 37338937 ↗
  • Mebazaa 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. PubMed 37589609 ↗
  • Soussi 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. PubMed 33216849 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Jul 2025, 18 months after the start.

Of 120 non-industry observational studies under Shock, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's planned 18 months is below that.

Counting every sponsor, half of 127 studies reached it within 26 months; a quarter within 12 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2024
First posted
Apr 19, 2024
StartActual
Jan 1, 2024
Primary completionEst.
Jul 1, 2025
CompletionEst.
Jan 1, 2026
Last update
Apr 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06376318
Lead sponsor
Saint-Louis Hospital, Paris, France
Collaborators
University of Helsinki, University of Ottawa, University of Leipzig, University of Nancy, McGill University, Mayo Clinic, University of Paris 5 - Rene Descartes, University of Toronto
Responsible party
Sabri SOUSSI (Assistant Professor, University of Toronto) — Principal investigator
First posted
Apr 19, 2024
Start date
Jan 1, 2024
Primary completion
Jul 1, 2025 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Apr 19, 2024

Study contacts

Claudia dos Santos, MD, PhD
principal investigator · Unity Health Toronto
Alexandre Mebazaa, MD, PhD
study chair · St Louis and Lariboisiere Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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