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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 21, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

January 10, 2022

Last Update Submit

July 18, 2023

Conditions

Keywords

Septic shockHeart dysfunctionPositron emission tomographyEnergy substrates (glucose, fatty acid, acetate)Mitochondrial activity

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.

Diagnostic Test: ultrasound cardiographyDiagnostic Test: FDG PET scanDiagnostic Test: Palmitate PET scanDiagnostic Test: Acetate PET scanDiagnostic Test: Blood sampling

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.

Diagnostic Test: ultrasound cardiographyDiagnostic Test: FDG PET scanDiagnostic Test: Palmitate PET scanDiagnostic Test: Acetate PET scanDiagnostic Test: Blood sampling

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.

Diagnostic Test: ultrasound cardiographyDiagnostic Test: FDG PET scanDiagnostic Test: Palmitate PET scanDiagnostic Test: Acetate PET scanDiagnostic Test: Blood sampling

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.

Diagnostic Test: ultrasound cardiographyDiagnostic Test: FDG PET scanDiagnostic Test: Palmitate PET scanDiagnostic Test: Acetate PET scanDiagnostic Test: Blood sampling

Interventions

Ultrasound to check heart functions and systolic ejection fraction.

Acute Heart Failure with preserved Ejection Fraction: HFpEFAcute Heart Failure with reduced Ejection Fraction: HFrEFSeptic shock with SIMD: SIMD+Septic shock without SIMD: SIMD-
FDG PET scanDIAGNOSTIC_TEST

FDG venous injection and positron emission tomography scan.

Also known as: FDG positron emission tomography
Acute Heart Failure with preserved Ejection Fraction: HFpEFAcute Heart Failure with reduced Ejection Fraction: HFrEFSeptic shock with SIMD: SIMD+Septic shock without SIMD: SIMD-
Palmitate PET scanDIAGNOSTIC_TEST

C11-Palmitate venous injection and positron emission tomography scan.

Also known as: Palmitate positron emission tomography
Acute Heart Failure with preserved Ejection Fraction: HFpEFAcute Heart Failure with reduced Ejection Fraction: HFrEFSeptic shock with SIMD: SIMD+Septic shock without SIMD: SIMD-
Acetate PET scanDIAGNOSTIC_TEST

C11-Acetate venous injection and positron emission tomography scan.

Also known as: Acetate positron emission tomography
Acute Heart Failure with preserved Ejection Fraction: HFpEFAcute Heart Failure with reduced Ejection Fraction: HFrEFSeptic shock with SIMD: SIMD+Septic shock without SIMD: SIMD-
Blood samplingDIAGNOSTIC_TEST

Collecting 20ml of venous blood.

Also known as: Collecting blood sample
Acute Heart Failure with preserved Ejection Fraction: HFpEFAcute Heart Failure with reduced Ejection Fraction: HFrEFSeptic shock with SIMD: SIMD+Septic shock without SIMD: SIMD-

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

Related Publications (58)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

20 ml of blood

MeSH Terms

Conditions

Shock, Septic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Olivier Lesur, MD PhD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Lesur, MD PhD

CONTACT

Frédéric Chagnon, MSc

CONTACT

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

Locations