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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Continous infusion of a commercially available ketone monoester via nasogastric tube.
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Prague, Czechia
RECRUITINGProportion of time within the target concentration range
Relative time of arterial blood concentration of 3-OHB being in the range of 2 - 3.5 mmol/L.
Time frame: 36 hours
Worsening of liver function
Increase of ALT, AST or GGT \> 2x from baseline
Time frame: During 72 hours within from start of the study intervention
GIT tolerance
Occurrence of repeated vomiting or patient-reported gastrointestinal intolerance considered to limit continuation of the infusion.
Time frame: During 36 hours of the study
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