Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

Not Applicable

Not yet recruiting

• Conditions: Sepsis Induced Cardiomyopathy

• Registration Number: NCT06952140
• Lead Sponsor: Tor Biering-Sørensen

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. .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-23
• Study First Posted: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-28
• Study Start: 2025-06-10
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Global longitudinal strain	From intervention to 3 hours after intervention (this is assessed for both treatment arms)	Echocardiographic measure obtained from transthoracic echocardiography

Secondary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	From intervention to 3 hours after intervention (this is assessed for both treatment arms)	Echocardiographic measure obtained from transthoracic echocardiography
Mean arterial pressure	From intervention to 3 hours after intervention (this is assessed for both treatment arms)	Obtained from invasive blood pressure measurement (arterial line)
Cardiac output	From intervention to 3 hours after intervention (this is assessed for both treatment arms)	Obtained from transthoracic echocardiography
Peripheral blood oxygen saturation	From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Arterial blood pH	From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Arterial blood lactate	From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Accumulated norepinephrine	From intervention to 3 hours after intervention (this is assessed for both treatment arms)