Cardiovascular Metabolic Remodeling in Shock (METASHOCK)

February 22, 2024 updated by: University Hospital, Rouen

Metabolic Remodeling Assessment During Severe Cardiovascular Dysfunction in Shock

The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To do this, the investigators chose to carry out an in-depth study of the different metabolic pathways, using metabolomic analysis of plasma, targeting the cardiovascular metabolism of patients admitted to intensive care for septic and non-septic shocks.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Rouen, France
        • University Hospital of Rouen
        • Contact:
          • Grégoire JOLLY, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients hospitalised in intensive care for shock, treated with a vasoactive or ionotropic amine, undergoing invasive mechanical ventilation for less than 24 hours

Description

Inclusion Criteria:

  • Patient aged between 18 and 75.
  • Patient admitted to intensive care for shock treated with a vasoactive or inotropic amine (adrenaline, dobutamine or noradrenaline).Patient undergoing invasive mechanical ventilation for less than 24 hours (or admitted to intensive care for less than 24 hours if the patient arrived intubated) and for a foreseeable duration of ventilation of at least 48 hours.
  • Patient, or relative if the patient is not competent, who has read and understood the information letter and does not object to participation in the research, or emergency procedure in the absence of a relative.
  • Urine or blood pregnancy test if a sample is taken as part of routine negative care (if woman of childbearing age).

Exclusion Criteria:

  • Moribund patient (death expected within < 24 hours) and/or decision to limit or stop treatment on admission to intensive care.
  • Pregnant, parturient or breast-feeding woman.
  • Patient not suitable for enteral calorie intake. Patient with a history of: advanced chronic renal failure ; advanced chronic liver failure.
  • Incapacitated patient of full age (under guardianship, curatorship) or deprived of liberty by court order.
  • Patient already taking part in an interventional study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock
Time Frame: Day 3
Correlation between plasma concentrations of metabolites at inclusion and delta of SOFA score (SOFA Day 1 - SOFA Day 3) with adjustment for SOFA at Day 1
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Grégoire JOLLY, MD, University Hospital of Rouen, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/387/OB
  • 2023-A00503-42 (Registry Identifier: Frecnh Ministry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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