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NCT Number: NCT06952140

Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

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. .

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Key information

Conditions

Sepsis Induced Cardiomyopathy Acid-Base Imbalance Acidosis Infections Inflammation Ketosis Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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

Treatment and study plan

Ketone ester

Dietary Supplement

Ketone ester: 3-hydroxybutyrate as enteral bolus (500 mg/kg)

Placebo

Dietary Supplement

Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus

Primary outcomes

  1. Global longitudinal strain

    Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)

    Echocardiographic measure obtained from transthoracic echocardiography

Secondary outcomes

  1. Left ventricular ejection fraction

    Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)

    Echocardiographic measure obtained from transthoracic echocardiography

  2. Mean arterial pressure

    Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)

    Obtained from invasive blood pressure measurement (arterial line)

  3. Cardiac output

    Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)

    Obtained from transthoracic echocardiography

  4. Peripheral blood oxygen saturation

    Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)

  5. Arterial blood pH

    Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)

  6. Arterial blood lactate

    Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)

  7. Accumulated norepinephrine

    Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)

Study contacts

Contact information is provided by the study sponsor or research team.

Katrine F Bernholm, MD

CONTACT

[email protected]

0045 24909488

Sponsors and collaborators

Lead sponsor

Tor Biering-Sørensen

Other

Registry information

Acronym: KetoSIC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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