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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-Hydroxybutyrate treatment | Experimental | KetoneAid Ketone Ester 0,5g/kg (max. 50g) bolus |
|
| Placebo Treatment | Placebo Comparator | Maltodextrin-base isocaloric placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KetoneAid Ketone Ester | Dietary Supplement | Commercially available ketone supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output (L/min) area under curve | Right Heart Catheterization (by thermodilution) | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac output (L/min) | Right Heart Catheterization (by thermodilution) | 1 hour |
| Left Ventricular Filling Pressure (mmHg) area under curve | Right Heart Catheterization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Central Jutland | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37452805 | Derived | Berg-Hansen K, Christensen KH, Gopalasingam N, Nielsen R, Eiskjaer H, Moller N, Birkelund T, Christensen S, Wiggers H. Beneficial Effects of Ketone Ester in Patients With Cardiogenic Shock: A Randomized, Controlled, Double-Blind Trial. JACC Heart Fail. 2023 Oct;11(10):1337-1347. doi: 10.1016/j.jchf.2023.05.029. Epub 2023 Jul 12. |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | Commercially available maltodextrin supplement |
|
| 3 hours |
| Cardiac Power Output (W) area under curve | mean arterial pressure x cardiac output/451 | 3 hours |
| Mixed Venous Saturation (%) area under curve | Right Heart Catheterization | 3 hours |
| Left Ventricular Ejection Fraction (%) area under curve | Echocardiography | 3 hours |
| Hourly urinary output (mL/hour) area under curve | 3 hours |
| Renal Perfusion (mL/min) | Renal doppler ultrasound | 1 hours |
| Arterial Lactate (mmol/L) area under curve | Arterial blood gas measurements | 3 hours |
| Cumulative doses of inotropes and vasopressors during the 3 hour studyperiod | 3 hours |
| Cerebral Perfusion area under curve | Near-infrared spectroscopy | 3 hours |
| Peripheral Perfusion area under curve | Near-infrared spectroscopy | 3 hours |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |