Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTor Biering-Sørensen

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

12 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution