Cardiovascular Metabolic Remodeling in Shock

Not yet recruiting

• Conditions: Shock

• Registration Number: NCT06285513
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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.

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 Timeline

• Status Verified: 2023-12
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Study Start: 2024-09
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock	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

Trial Locations

Locations (1)

University Hospital of Rouen; 🇫🇷 Rouen, France