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Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock (KETO-SHOCK1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04642768
Recruitment Status : Completed
First Posted : November 24, 2020
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
Kristoffer Berg-Hansen, University of Aarhus

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Cardiogenic Shock Dietary Supplement: KetoneAid Ketone Ester Dietary Supplement: Maltodextrin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : May 17, 2022
Actual Study Completion Date : May 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: 3-Hydroxybutyrate treatment
KetoneAid Ketone Ester 0,5g/kg (max. 50g) bolus
 Dietary Supplement: KetoneAid Ketone Ester
Commercially available ketone supplement
Placebo Comparator: Placebo Treatment
Maltodextrin-base isocaloric placebo
 Dietary Supplement: Maltodextrin
Commercially available maltodextrin supplement


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac Output (L/min) area under curve [ Time Frame: 3 hours ]
    Right Heart Catheterization (by thermodilution)


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642768


Locations
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Denmark
Aarhus University Hospital
Aarhus, Midtjylland, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
More Information
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Responsible Party: Kristoffer Berg-Hansen, Principal Investigator, University of Aarhus
ClinicalTrials.gov Identifier: NCT04642768    
Other Study ID Numbers: KETO-SHOCK 1-10-72-209-20
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristoffer Berg-Hansen, University of Aarhus:
Ketone bodies
β-hydroxybutyrate
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Infarction
Ischemia
Necrosis