About this trial
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. .
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ketone ester
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Tor Biering-Sørensen
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution