Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

Launched by TOR BIERING-SØRENSEN · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of ketone esters on heart function in patients who have sepsis-induced cardiomyopathy, a condition where the heart struggles to pump effectively due to severe infection. Researchers believe that ketone esters may help improve heart function and reduce the amount of oxygen the body uses, which could be particularly beneficial for patients in the intensive care unit (ICU). This study will compare the effects of ketone esters to a placebo (an inactive substance) to see if they can make a positive difference in these patients.

To participate in this trial, individuals must be at least 18 years old and admitted to the ICU with a heart function measurement indicating significant impairment. They should have a suspected or confirmed infection, but they cannot have a history of heart failure before their ICU admission or other specific medical issues. Participants can expect to receive either the ketone ester treatment or a placebo, and their heart function will be closely monitored throughout the study. This research aims to provide insights that could lead to new treatments for patients facing severe infections that affect heart health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥ 18 years of age admitted to the the intensive care unit (ICU)
• • LVEF \< 40% determined by a screening echocardiography (two projections: apical 4 chamber and 2 chamber) 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)
• Exclusion Criteria:
• • 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