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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
Phase
First received
Last updated
Start date September 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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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