Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

ConditionSepsis Induced Cardiomyopathy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorTor Biering-Sørensen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

12 Participants

are divided into 2 treatment groups

Group A: Ketone ester followed by placeboExperimental treatment 2 interventions

Group B: Placebo followed by ketone esterExperimental treatment 2 interventions

Trial outcomes