Background Cardiogenic shock is a life-threatening state of acute heart failure with severely depressed blood pressure and organ perfusion. The 30-day mortality is reported as high as 50%. To date, no randomized trial has documented a survival benefit of any medical treatment in this patient group. In a first-in-man study the investigators have recently discovered that treatment with ketone bodies increases cardiac output by 2 liters per minute. Objective The present study aims to examine the direct effects of ketone body supplements on the heart function in patients hospitalized with cardiogenic shock. Also, the aim is to determine the relative need for medical circulatory support following ketone body supplement. Design A randomized double-blind cross-over study of the hemodynamic effect of enteral ketone ester versus placebo in 12 patients with cardiogenic shock Methods Right heart catheterization will be installed to monitor cardiac pressures and output. The investigators will observe heart function with transthoracic echocardiography. Blood- and urine samples will be analyzed for electrolytes, energy substrates and vasoactive substances. Organ perfusion is to be examined by renal ultrasonography and near-infrared spectroscopy for measuring cerebral and peripheral circulation. Perspectives This investigation may grant essential knowledge on ketosis in cardiogenic shock. This may lead to larger clinical trials, and hopefully a new and better treatment for patients with cardiogenic shock.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
13
Commercially available ketone supplement
Commercially available maltodextrin supplement
Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Cardiac Output (L/min) area under curve
Right Heart Catheterization (by thermodilution)
Time frame: 3 hours
Cardiac output (L/min)
Right Heart Catheterization (by thermodilution)
Time frame: 1 hour
Left Ventricular Filling Pressure (mmHg) area under curve
Right Heart Catheterization
Time frame: 3 hours
Cardiac Power Output (W) area under curve
mean arterial pressure x cardiac output/451
Time frame: 3 hours
Mixed Venous Saturation (%) area under curve
Right Heart Catheterization
Time frame: 3 hours
Left Ventricular Ejection Fraction (%) area under curve
Echocardiography
Time frame: 3 hours
Hourly urinary output (mL/hour) area under curve
Time frame: 3 hours
Renal Perfusion (mL/min)
Renal doppler ultrasound
Time frame: 1 hours
Arterial Lactate (mmol/L) area under curve
Arterial blood gas measurements
Time frame: 3 hours
Cumulative doses of inotropes and vasopressors during the 3 hour studyperiod
Time frame: 3 hours
Cerebral Perfusion area under curve
Near-infrared spectroscopy
Time frame: 3 hours
Peripheral Perfusion area under curve
Near-infrared spectroscopy
Time frame: 3 hours
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