Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketone ester, Placebo.
- Who it may be relevant to
- Registry conditions: Sepsis Induced Cardiomyopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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. .
Interventions
- Dietary supplement Ketone ester
Ketone ester: 3-hydroxybutyrate as enteral bolus (500 mg/kg) - Dietary supplement Placebo
Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus
Primary outcome measures
- Global longitudinal strain [Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]
Secondary outcome measures (7)
- Left ventricular ejection fraction [Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]
- Mean arterial pressure [Time frame: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]
- Cardiac output [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)]
Eligibility criteria
Inclusion criteria
- 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)
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06952140 · KetoSIC