Recruiting

Observational Study

Sponsor:

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Code:

NCT05202938

Conditions

Septic Shock

Chronic Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ultrasound cardiography

FDG PET scan

Palmitate PET scan

Acetate PET scan

Blood sampling

Study Details

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.

Conditions

Septic Shock

Chronic Heart Failure

Study ID

NCT05202938

Start date

Jul 21, 2022

Status verified date

Jul, 2023

Completion date

Jul 21, 2024

Anticipated

Primary completion date

Dec 21, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients hospitalized in intensive care unit and coronary unit of the Sherbrooke hospital/CHUS.
  • Accepts healthy volunteers: 4 to 6 age- and sex-matched HV will be recruited and imaged at the end of the inclusion window for the assessment of cardiac energy tracer's uptake and as ref. controls.

Exclusion Criteria:

  • 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

Study Design

Enrollment

32 participants

Anticipated

Interventions and Outcome Measures

Arms

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 cardiography

Ultrasound to check heart functions and systolic ejection fraction.

FDG PET scan

FDG venous injection and positron emission tomography scan.

Palmitate PET scan

C11-Palmitate venous injection and positron emission tomography scan.

Acetate PET scan

C11-Acetate venous injection and positron emission tomography scan.

Blood sampling

Collecting 20ml of venous blood.

Primary outcome measure

  • FDG PET scan [ Time Frame: 25 minutes ]
  • Palmitate PET scan [ Time Frame: 15 minutes ]
  • Acetate PET scan [ Time Frame: 10 minutes ]
  • Quantitative study of blood FDG:palmitate balance. [ Time Frame: 20 minutes ]

Central Contacts and Locations

Central contacts

Olivier Lesur, MD PhD

819-346-1110olivier.lesur@usherbrooke.ca

Frédéric Chagnon, MSc

819-346-1110frederic.chagnon@usherbrooke.ca

Locations

CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H5N4

More Information

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Last update posted

Jul 20, 2023

Last verified

Jul, 2023

Keywords

  • Septic shock
  • Heart dysfunction
  • Positron emission tomography
  • Energy substrates (glucose, fatty acid, acetate)
  • Mitochondrial activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de recherche du Centre hospitalier universitaire de Sherbrooke on 2023-07-20.