eMESH Struct. 2022-23
eMESH
Energy MEtabolism of Septic Heart.
2 other identifiers
observational
32
1 country
1
Brief Summary
A flexible energy metabolism matched with the contractile needs of the muscle is essential to a normal heart. Loss of metabolic flexibility and cardiac systolic efficiency coexist in Sepsis-induced Myocardial Dysfunction (SIMD), a phenomenon attributed to mitochondrial dysfunction and mishandling of energy substrates. Cardiac positron emission tomography (PET) could allow to quantify non invasively the selection of energy substrates by the hearts in sepsis and will be associated in parallel with functional status (ultrasound cardiography), injury biomarkers, apelinergic and metabolomic blood profiles. Comparisons will be performed between septic and acute on chronic heart failures, with or without systolic dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
January 24, 2022
CompletedStudy Start
First participant enrolled
July 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2024
CompletedJuly 20, 2023
July 1, 2023
1.4 years
January 10, 2022
July 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
FDG PET scan
Positron emission tomography with FDG radiotracer. It will report the glucose uptake by the heart.
25 minutes
Palmitate PET scan
Positron emission tomography with C11-palmitate radiotracer. It will report the fatty acid uptake by the heart.
15 minutes
Acetate PET scan
Positron emission tomography with C11-acetate radiotracer. It will report the acetate uptake by the heart.
10 minutes
Quantitative study of blood FDG:palmitate balance.
Measure of the blood FDG:palmitate balance by spectroscopy LC-MS and NMR.
20 minutes
Secondary Outcomes (3)
Measure of myocardial injury biomarkers.
45 minutes
Measure of apelinergics.
45 minutes
Profiling of the systemic metabolomic.
45 minutes
Study Arms (4)
Septic shock with SIMD: SIMD+
8 patients in septic shock (Sepsis-3-) with SIMD: ejection fraction (LVEF) \< 45% in the first 48 hours of admission into the intensive care unit. No prior cardiac ultrasound or normal cardiac ultrasound values less than 2 years ago , or an ino-vasotropic infusion (milrinone, dobutamine, norepinephrine or epinephrine) required to obtain a LVEF ≥ 45%, or a drop of ≥ 20% compared to the LVEF value record ed less than 2 years ago.
Septic shock without SIMD: SIMD-
8 patients in septic shock (Sepsis-3) without SIMD. Ejection fraction (LVEF) ≥ 45% with or without ino-vasotropic infusion (milrinone, dobutamine, norepinephrine or epinephrine), or similar to the LVEF recorded less than 2 years ago.
Acute Heart Failure with reduced Ejection Fraction: HFrEF
8 patients with acutely reduced ejection fraction (LVEF) \< 50%. with or without ino-vasotropic infusion (milrinone, dobutamine, norepinephrine or epinephrine) No prior cardiac ultrasound, or normal cardiac ultrasound values less than 2 years ago, or a drop of ≥ 20% compared to the LVEF recorded less than 2 years ago. No evidence of sepsis or septic shock.
Acute Heart Failure with preserved Ejection Fraction: HFpEF
8 patients with acute heart failure and a preserved ejection fraction (ejection fraction (LVEF ≥ 50% or similar to normal cardiac ultrasound values recorded less than 2 years ago). No evidence of septic shock.
Interventions
Ultrasound to check heart functions and systolic ejection fraction.
FDG venous injection and positron emission tomography scan.
C11-Palmitate venous injection and positron emission tomography scan.
C11-Acetate venous injection and positron emission tomography scan.
Collecting 20ml of venous blood.
Eligibility Criteria
Patients hospitalized in intensive care unit and coronary unit of the Sherbrooke hospital/CHUS.
You may qualify if:
- Patients hospitalized in intensive care unit and coronary unit of the Sherbrooke hospital/CHUS.
You may not qualify if:
- Pediatric patients
- Albumin allergy
- Moribund patients
- Patients too much unstable for the imaging procedure (clinical judgment)
- Unavailable tracers, staff, PET scan in a maximum delay of 72 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHUS
Sherbrooke, Quebec, J1H5N4, Canada
Related Publications (58)
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PMID: 27571457RESULTCoquerel D, Chagnon F, Sainsily X, Dumont L, Murza A, Cote J, Dumaine R, Sarret P, Marsault E, Salvail D, Auger-Messier M, Lesur O. ELABELA Improves Cardio-Renal Outcome in Fatal Experimental Septic Shock. Crit Care Med. 2017 Nov;45(11):e1139-e1148. doi: 10.1097/CCM.0000000000002639.
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PMID: 29629988RESULT
Biospecimen
20 ml of blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Lesur, MD PhD
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2022
First Posted
January 24, 2022
Study Start
July 21, 2022
Primary Completion
December 21, 2023
Study Completion
July 21, 2024
Last Updated
July 20, 2023
Record last verified: 2023-07