Sepsis Induced CardiomyopathyKetoSICNCT06952140
Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
A study testing Ketone ester in people with Sepsis Induced Cardiomyopathy, run by Tor Biering-Sørensen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis Induced Cardiomyopathy
- What is being tested?
- Ketone ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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. .
- Conditions
- Sepsis Induced Cardiomyopathy
- Being tested
- Ketone ester, Placebo
- Keywords
- Sepsis induced cardiomyopathy, Sepsis, Hemodynamics, Ketone ester, Ketones, Echocardiography, Randomized controlled trial, Cross-over trial, Cardiovascular
- Medical subject headings
- Sepsis, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone esterDietary supplement
Ketone ester: 3-hydroxybutyrate as enteral bolus (500 mg/kg)
PlaceboDietary supplement
Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus
| Study group | Role | What they receive |
|---|---|---|
| Ketone ester followed by placebo | Experimental | Not described Receives: Dietary Supplement: Ketone ester; Dietary Supplement: Placebo |
| Placebo followed by ketone ester | Experimental | Not described Receives: Dietary Supplement: Ketone ester; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global longitudinal strain
Echocardiographic measure obtained from transthoracic echocardiography
Measured: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Secondary outcomes (7)
Left ventricular ejection fraction
Echocardiographic measure obtained from transthoracic echocardiography
Measured: 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)
Measured: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Cardiac output
Obtained from transthoracic echocardiography
Measured: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Peripheral blood oxygen saturation
Measured: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Arterial blood pH
Measured: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Arterial blood lactate
Measured: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Accumulated norepinephrine
Measured: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start10 Mar 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis Induced CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
- Investigators
- Tor Biering-Sørensen, MD, MPH, MSc, PhD, Principal investigator, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952140
- Sponsor's protocol ID
- KetoSIC
- Acronym
- KetoSIC
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No