Cardiovascular Metabolic Remodeling in Shock

NCT ID: NCT06285513

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-02-28

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.

Conditions

Shock

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

GlycoCheck; Indirect calorimetry (in case of artificial ventilation)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grégoire JOLLY, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Rouen, France

Locations

University Hospital of Rouen

Rouen, , France

Countries

France

Central Contacts

Grégoire JOLLY, MD

Role: CONTACT

Gregoire.Jolly@chu-rouen.fr

02 32 88 24 50 ext. +33

Zoe DEMAILLY, MD

Role: CONTACT

Zoe.Demailly@chu-rouen.fr

Facility Contacts

Grégoire JOLLY, MD

Role: primary

Other Identifiers

2023-A00503-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021/387/OB

Identifier Type: -

Identifier Source: org_study_id