Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
NCT ID: NCT06952140
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
12 participants
INTERVENTIONAL
2025-06-10
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Ketone ester followed by placebo
Ketone ester
Ketone ester: 3-hydroxybutyrate as enteral bolus (500 mg/kg)
Placebo
Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus
Placebo followed by ketone ester
Ketone ester
Ketone ester: 3-hydroxybutyrate as enteral bolus (500 mg/kg)
Placebo
Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus
Interventions
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Ketone ester
Ketone ester: 3-hydroxybutyrate as enteral bolus (500 mg/kg)
Placebo
Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tor Biering-Sørensen
OTHER
Responsible Party
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Tor Biering-Sørensen
Professor, MD, MSc, MPH, PhD
Principal Investigators
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Tor Biering-Sørensen, MD, MPH, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Central Contacts
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Other Identifiers
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KetoSIC
Identifier Type: -
Identifier Source: org_study_id
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