Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy (KetoSIC)

Tor Biering-Sørensen

Status: Not yet enrolling

Conditions: Sepsis Induced Cardiomyopathy

Treatments: Dietary Supplement: Ketone ester; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06952140

KetoSIC

Details and patient eligibility

About

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. .

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

Ketone ester followed by placebo

Experimental group

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Ketone ester

Placebo followed by ketone ester

Experimental group

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Ketone ester