Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

Обзор

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. .

Вмешательства

• Пищевая добавка Ketone ester
  Ketone ester: 3-hydroxybutyrate as enteral bolus (500 mg/kg)
• Пищевая добавка Placebo
  Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus

Первичные конечные точки

• Global longitudinal strain [Срок оценки: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]

Вторичные конечные точки (7)

• Left ventricular ejection fraction [Срок оценки: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]
• Mean arterial pressure [Срок оценки: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]
• Cardiac output [Срок оценки: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]
• Peripheral blood oxygen saturation [Срок оценки: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]
• Arterial blood pH [Срок оценки: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]
• Arterial blood lactate [Срок оценки: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]
• Accumulated norepinephrine [Срок оценки: From intervention to 3 hours after intervention (this is assessed for both treatment arms)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06952140 · KetoSIC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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