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NCT06952140 | NOT YET RECRUITING | Sepsis Induced Cardiomyopathy

Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
Sponsor:

Tor Biering-Sørensen

Information provided by (Responsible Party):

Tor Biering-Sørensen

Brief 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 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, we 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. .

Condition or disease

Sepsis Induced Cardiomyopathy

Intervention/treatment

Ketone ester

Placebo

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
Actual Study Start Date : 2025-05-10
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2026-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

Location Details

NCT06952140

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