NCT04642768

Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	KetoneAid Ketone Ester	Commercially available ketone supplement
DIETARY_SUPPLEMENT	Maltodextrin	Commercially available maltodextrin supplement

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-05-17
• Completion: 2022-05-17
• First posted: 2020-11-24
• Last updated: 2022-05-20

Locations

1 site across 1 country: Denmark