Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

Starting soon · Not applicable · Has a placebo group

Conditions studied: Sepsis Induced Cardiomyopathy

In brief

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. .

Key facts

Study ID

NCT06952140

Run by

Tor Biering-Sørensen

People needed

12

Starts

2026-03-10

Expected to finish

2027-12-31

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥ 18 years of age admitted to the the intensive care unit (ICU)
• LVEF < 50% determined by a screening echocardiography and analysed according to the Simpson biplane method
• Ability for study personnel to perform transthoracic echocardiography
• Suspected or documented infection (suspected infection is defined as ongoing antibiotic treatment and/or body fluid culture sampling performed within 72 hours before screening)

You may not qualify if…

• Diagnosis of heart failure with reduced ejection fraction prior to ICU admission according to health records
• Surgical cause of ICU admission
• For patients in shock: Other primary causes of shock than sepsis (i.e. hypovolemia, haemorrhage, cardiogenic etiology, pulmonary embolism, anaphylaxis)
• Blood pH < 7.20
• Severe gastroparesis
• Inability to position a nasogastric tube

Full record on ClinicalTrials.gov

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