Cardiovascular Metabolic Remodeling in Shock

Shock Clinical Trial

— METASHOCK  

Official title:

Metabolic Remodeling Assessment During Severe Cardiovascular Dysfunction in Shock

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06285513
• Other study ID #: 2021/387/OB
• Secondary ID: 2023-A00503-42
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: February 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Rouen
• Contact: Grégoire JOLLY, MD
• Phone: 02 32 88 24 50
• Email: Gregoire.Jolly[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shock

Intervention

Diagnostic Test:
• Cardiac ultrasound
Cardiac ultrasound : determination of impairment of cardiac function by echocardiographic analysis (at V1, V3 and V4), Glycocheck : automatic analysis of sublingual microcirculation, Indirect calorimetry : determining the increase in energy expenditure in patients with septic shock

Locations

Country	Name	City	State
France	University Hospital of Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock	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