An interventional study of Ketone ester and Placebo in Sepsis Induced Cardiomyopathy, sponsored by Tor Biering-Sørensen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Tor Biering-Sørensen · Not applicable, Interventional, and Treatment
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. .
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 12 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Tor Biering-Sørensen is the lead sponsor of 22 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Ketone ester · Dietary Supplement: Placebo
Dietary Supplement: Ketone ester · Dietary Supplement: Placebo
Ketone ester: 3-hydroxybutyrate as enteral bolus (500 mg/kg)
Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus
Global longitudinal strain
Echocardiographic measure obtained from transthoracic echocardiography
Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Left ventricular ejection fraction
Echocardiographic measure obtained from transthoracic echocardiography
Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Mean arterial pressure
Obtained from invasive blood pressure measurement (arterial line)
Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Cardiac output
Obtained from transthoracic echocardiography
Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Peripheral blood oxygen saturation
Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Arterial blood pH
Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Arterial blood lactate
Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Accumulated norepinephrine
Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beta-hydroxybutyrate-1,3-butanediol monoester
Tor Biering-Sørensen