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Not Yet RecruitingNCT06952140

Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
12 (estimated)
Sponsor
Tor Biering-Sørensen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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. .

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTKetone esterKetone ester: 3-hydroxybutyrate as enteral bolus (500 mg/kg)
DIETARY_SUPPLEMENTPlaceboMaltodextrin (isovolumic and isocaloric placebo) as enteral bolus

Timeline

Start date
2026-03-10
Primary completion
2027-07-01
Completion
2027-12-31
First posted
2025-04-30
Last updated
2026-03-04

Source: ClinicalTrials.gov record NCT06952140. Inclusion in this directory is not an endorsement.