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NCT Number: NCT04642768

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

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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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KetoneAid Ketone Ester

Dietary Supplement

Commercially available ketone supplement

Maltodextrin

Dietary Supplement

Commercially available maltodextrin supplement

Primary outcomes

  1. Cardiac Output (L/min) area under curve

    Time frame: 3 hours

    Right Heart Catheterization (by thermodilution)

Secondary outcomes

  1. Cardiac output (L/min)

    Time frame: 1 hour

    Right Heart Catheterization (by thermodilution)

  2. Left Ventricular Filling Pressure (mmHg) area under curve

    Time frame: 3 hours

    Right Heart Catheterization

  3. Cardiac Power Output (W) area under curve

    Time frame: 3 hours

    mean arterial pressure x cardiac output/451

  4. Mixed Venous Saturation (%) area under curve

    Time frame: 3 hours

    Right Heart Catheterization

  5. Left Ventricular Ejection Fraction (%) area under curve

    Time frame: 3 hours

    Echocardiography

  6. Hourly urinary output (mL/hour) area under curve

    Time frame: 3 hours

  7. Renal Perfusion (mL/min)

    Time frame: 1 hours

    Renal doppler ultrasound

  8. Arterial Lactate (mmol/L) area under curve

    Time frame: 3 hours

    Arterial blood gas measurements

  9. Cumulative doses of inotropes and vasopressors during the 3 hour studyperiod

    Time frame: 3 hours

  10. Cerebral Perfusion area under curve

    Time frame: 3 hours

    Near-infrared spectroscopy

  11. Peripheral Perfusion area under curve

    Time frame: 3 hours

    Near-infrared spectroscopy

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: KETO-SHOCK1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2020
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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