Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Proportion of time within the target concentration range
研究概览
简要总结
This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction.
详细描述
Adult patients with left ventricular ejection fraction (LVEF) <35% admitted to the intensive care unit for acutely decompensated heart failure with low cardiac output syndrome or cardiogenic shock will receive a continuous infusion of D-3-hydroxybutyrate (3-OHB) monoester via a nasogastric tube for 36 hours. The infusion rate will be iteratively adjusted to achieve an arterial blood concentration of 3-OHB of 2-3.5 mmol/L. Arterial blood concentrations of 3-OHB will be measured every 1-3 hours using point-of-care testing. The primary endpoint will be the proportion of time within the target concentration range. Secondary safety endpoints will include worsening of liver function not attributable to hemodynamic deterioration, occurrence of cardiac arrhythmias, and gastrointestinal tolerance of the infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •LVEF <35%
- •Acute heart failure with low cardiac output syndrome or cardiogenic shock
排除标准
- •Severe liver failure
- •Severe acidosis
- •Inability to insert nasogastric tube
- •Gastric paralysis / ileus
- •Repeated vomiting
- •Severe hypokalemia
研究组 & 干预措施
Treated patients
Observational cohort of patients receiving 3-OHB
干预措施: Ketone Monoester (KE) (Dietary Supplement)
结局指标
主要结局
Proportion of time within the target concentration range
时间窗: 36 hours
Relative time of arterial blood concentration of 3-OHB being in the range of 2 - 3.5 mmol/L.
次要结局
- Worsening of liver function(During 72 hours within from start of the study intervention)
- GIT tolerance(During 36 hours of the study)
研究者
Marek Sramko, MD, PhD
Head of Department of Acute Cardiology
Institute for Clinical and Experimental Medicine