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

Cardiogenic Shock Clinical Trial

— KETO-SHOCK1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642768
• Other study ID #: KETO-SHOCK 1-10-72-209-20
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 17, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ongoing treatment with inotropes and/or vasopressors because of cardiogenic shock as judged by the clinicians

• Patients are required at some point in time to have had > 1 of the following: systolic blood pressure < 90 mmHg; arterial blood lactate = 2.5mmol/l; organ hypoperfusion (e.g. urinary output < 0.5 ml/kg/hour or SvO2 <55% with normal PaO2 and Hgb)

• LVEF < 40%

• Age = 18 years

Exclusion Criteria:

• Other primary causes of shock (hypovolemia, hemorrhage, severe infection or sepsis, pulmonary embolism or anaphylaxis),

• Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall)

• INTERMACS level 1 or 2 [18] with unstable or sliding hemodynamics on inotropes/vasopressors

• Use of or probable need for mechanic circulatory support (e.g. left ventricular assistant device, IMPELLA, extracorporeal membrane oxygenation)

• Recent post-cardiotomy cardiogenic shock (defined as thoracic surgery with the last 3 days)

• Inability to position a nasogastric tube

• Severe gastroparesis or abdominal distension

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Dietary Supplement:
• KetoneAid Ketone Ester
Commercially available ketone supplement
• Maltodextrin
Commercially available maltodextrin supplement

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output (L/min) area under curve	Right Heart Catheterization (by thermodilution)	3 hours
Secondary	Cardiac output (L/min)	Right Heart Catheterization (by thermodilution)	1 hour
Secondary	Left Ventricular Filling Pressure (mmHg) area under curve	Right Heart Catheterization	3 hours
Secondary	Cardiac Power Output (W) area under curve	mean arterial pressure x cardiac output/451	3 hours
Secondary	Mixed Venous Saturation (%) area under curve	Right Heart Catheterization	3 hours
Secondary	Left Ventricular Ejection Fraction (%) area under curve	Echocardiography	3 hours
Secondary	Hourly urinary output (mL/hour) area under curve		3 hours
Secondary	Renal Perfusion (mL/min)	Renal doppler ultrasound	1 hours
Secondary	Arterial Lactate (mmol/L) area under curve	Arterial blood gas measurements	3 hours
Secondary	Cumulative doses of inotropes and vasopressors during the 3 hour studyperiod		3 hours
Secondary	Cerebral Perfusion area under curve	Near-infrared spectroscopy	3 hours
Secondary	Peripheral Perfusion area under curve	Near-infrared spectroscopy	3 hours