Cardiovascular Metabolic Remodeling in Shock

NCT06285513 | Not Yet Recruiting

• 2 other identifiers: 2021/387/OB2023-A00503-42
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock

Keywords

Metabolic remodelling; Shock states; Cardiovascular dysfunction; Metabolomics

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Cardiac ultrasound DIAGNOSTIC_TEST

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

Also known as: GlycoCheck, Indirect calorimetry (in case of artificial ventilation)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Hospital of Rouen

Rouen, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grégoire JOLLY, MD

  University Hospital of Rouen, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grégoire JOLLY, MD

CONTACT

02 32 88 24 50; Gregoire.Jolly@chu-rouen.fr

Zoe DEMAILLY, MD

CONTACT

Zoe.Demailly@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 29, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)