Clinical trial NCT06952140: Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
Official title: Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sepsis Induced Cardiomyopathy
Keywords: Sepsis induced cardiomyopathy
Sepsis
Hemodynamics
Ketone ester
Ketones
Echocardiography
Randomized controlled trial
Cross-over trial
Cardiovascular
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: As this is a cross-over trial participants will receive both active treatment and placebo. Participants will be randomized 1:1 to receive A) active treatment followed by placebo or B) placebo followed by active treatment.
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Global longitudinal strain
timeFrame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Secondary outcomes:
measure: Left ventricular ejection fraction
timeFrame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
measure: Mean arterial pressure
timeFrame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
measure: Cardiac output
timeFrame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
measure: Peripheral blood oxygen saturation
timeFrame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
measure: Arterial blood pH
timeFrame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
measure: Arterial blood lactate
timeFrame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
measure: Accumulated norepinephrine
timeFrame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Other outcomes:
Locations:
Study officials:
affiliation: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
name: Tor Biering-Sørensen, MD, MPH, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: