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Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

Study acronym: KetoSIC
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Jul 1, 2026 to Jul 1, 2027
    • Start date: Jun 10, 2025 to Mar 10, 2026
    • Study completion date: Jul 1, 2026 to Dec 31, 2027
    • Eligibility criteria shortened, about 8 words
    v3
  2. Start date: May 10, 2025 to Jun 10, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with a high mortality rate in the ICU. Sepsis induced cardiomyopathy (SICM) is a multi-factorial process that appears in approximately 50% of patients with sepsis/septic shock and is associated with increased mortality. It is suggested that ketone bodies are more efficient substrates of energy metabolism than glucose, with a lower oxygen consumption per ATP-molecule produced and that the failing human heart increases the capacity to metabolize ketones. Previous studies have found acute beneficial hemodynamic effects of ketone esters in patients with chronic heart failure and cardiogenic shock, respectively. Improved hemodynamics and reduced systemic oxygen consumption as an effect of ketone esters might be of great benefit in patients admitted to the ICU. Thus, the investigators aim to investigate the hemodynamic effects of ketone esters in patients with sepsis induced cardiomyopathy in this randomized, placebo-controlled, double-blinded, cross-over, acute intervention study. .
Trial Details
NCT Number NCT06952140
Lead Sponsor Tor Biering-Sørensen
Conditions
(from sponsor)		 Sepsis Induced Cardiomyopathy
Related terms Ketosis, Sepsis
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov