Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

NCT ID: NCT06952140

Last Updated: 2025-05-28

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2026-07-01

Brief Summary

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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. .

Detailed Description

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Conditions

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Sepsis Induced Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ketone ester followed by placebo

Group Type EXPERIMENTAL

Ketone ester

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus

Placebo followed by ketone ester

Group Type EXPERIMENTAL

Ketone ester

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 18 years of age admitted to the the intensive care unit (ICU)
* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tor Biering-Sørensen

OTHER

Sponsor Role lead

Responsible Party

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Tor Biering-Sørensen

Professor, MD, MSc, MPH, PhD

Responsibility Role SPONSOR_INVESTIGATOR

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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Katrine F Bernholm, MD

Role: CONTACT

0045 24909488

Other Identifiers

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KetoSIC

Identifier Type: -

Identifier Source: org_study_id

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