Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- Global longitudinal strain
研究概览
简要总结
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. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Placebo followed by ketone ester
干预措施: Placebo (Dietary Supplement)
Ketone ester followed by placebo
干预措施: Placebo (Dietary Supplement)
Placebo followed by ketone ester
干预措施: Ketone ester (Dietary Supplement)
Ketone ester followed by placebo
干预措施: Ketone ester (Dietary Supplement)
结局指标
主要结局
Global longitudinal strain
时间窗: From intervention to 3 hours after intervention (this is assessed for both treatment arms)
Echocardiographic measure obtained from transthoracic echocardiography
次要结局
- Mean arterial pressure(From intervention to 3 hours after intervention (this is assessed for both treatment arms))
- Left ventricular ejection fraction(From intervention to 3 hours after intervention (this is assessed for both treatment arms))
- Cardiac output(From intervention to 3 hours after intervention (this is assessed for both treatment arms))
- Arterial blood lactate(From intervention to 3 hours after intervention (this is assessed for both treatment arms))
- Peripheral blood oxygen saturation(From intervention to 3 hours after intervention (this is assessed for both treatment arms))
- Arterial blood pH(From intervention to 3 hours after intervention (this is assessed for both treatment arms))
- Accumulated norepinephrine(From intervention to 3 hours after intervention (this is assessed for both treatment arms))
研究者
Tor Biering-Sørensen
Professor, MD, MSc, MPH, PhD
Herlev and Gentofte Hospital