Cardiogenic ShockKETO-SHOCK1NCT04642768
Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock
A study testing KetoneAid Ketone Ester and Maltodextrin in people with Cardiogenic Shock, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- KetoneAid Ketone Ester and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 17 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- KetoneAid Ketone Ester, Maltodextrin
- Keywords
- Ketone bodies, β-hydroxybutyrate
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoneAid Ketone EsterDietary supplement
Commercially available ketone supplement
MaltodextrinDietary supplement
Commercially available maltodextrin supplement
| Study group | Role | What they receive |
|---|---|---|
| 3-Hydroxybutyrate treatment | Experimental | KetoneAid Ketone Ester 0,5g/kg (max. 50g) bolus Receives: Dietary Supplement: KetoneAid Ketone Ester |
| Placebo Treatment | Placebo comparator | Maltodextrin-base isocaloric placebo Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output (L/min) area under curve
Right Heart Catheterization (by thermodilution)
Measured: 3 hours
Secondary outcomes (11)
Cardiac output (L/min)
Right Heart Catheterization (by thermodilution)
Measured: 1 hour
Left Ventricular Filling Pressure (mmHg) area under curve
Right Heart Catheterization
Measured: 3 hours
Cardiac Power Output (W) area under curve
mean arterial pressure x cardiac output/451
Measured: 3 hours
Mixed Venous Saturation (%) area under curve
Right Heart Catheterization
Measured: 3 hours
Left Ventricular Ejection Fraction (%) area under curve
Echocardiography
Measured: 3 hours
Hourly urinary output (mL/hour) area under curve
Measured: 3 hours
Renal Perfusion (mL/min)
Renal doppler ultrasound
Measured: 1 hours
Arterial Lactate (mmol/L) area under curve
Arterial blood gas measurements
Measured: 3 hours
Cumulative doses of inotropes and vasopressors during the 3 hour studyperiod
Measured: 3 hours
Cerebral Perfusion area under curve
Near-infrared spectroscopy
Measured: 3 hours
Peripheral Perfusion area under curve
Near-infrared spectroscopy
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Jan 2021
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristoffer Berg-Hansen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642768
- Sponsor's protocol ID
- KETO-SHOCK 1-10-72-209-20
- Acronym
- KETO-SHOCK1
- Status last verified
- May 2022
- First submitted
- 18 Nov 2020
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37452805
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT04642768
- Acronym / sponsor ID
- KETO-SHOCK1 / KETO-SHOCK 1-10-72-209-20
- Conditions
- Cardiogenic Shock
- Keywords
- Ketone bodies, β-hydroxybutyrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-Hydroxybutyrate treatment | Experimental | Dietary Supplement: KetoneAid Ketone EsterKetoneAid Ketone Ester 0,5g/kg (max. 50g) bolus |
| Placebo Treatment | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin-base isocaloric placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetoneAid Ketone EsterCommercially available ketone supplement | Dietary supplement | 3-Hydroxybutyrate treatment |
| MaltodextrinCommercially available maltodextrin supplement | Dietary supplement | Placebo Treatment |
Primary outcome
Cardiac Output (L/min) area under curve
Time frame: 3 hours
Right Heart Catheterization (by thermodilution)
11 secondary outcomes
Cardiac output (L/min)
Time frame: 1 hour
Left Ventricular Filling Pressure (mmHg) area under curve
Time frame: 3 hours
Cardiac Power Output (W) area under curve
Time frame: 3 hours
Mixed Venous Saturation (%) area under curve
Time frame: 3 hours
Left Ventricular Ejection Fraction (%) area under curve
Time frame: 3 hours
Hourly urinary output (mL/hour) area under curve
Time frame: 3 hours
Renal Perfusion (mL/min)
Time frame: 1 hours
Arterial Lactate (mmol/L) area under curve
Time frame: 3 hours
Cumulative doses of inotropes and vasopressors during the 3 hour studyperiod
Time frame: 3 hours
Cerebral Perfusion area under curve
Time frame: 3 hours
Peripheral Perfusion area under curve
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 37452805Berg-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KetoneAid Ketone Ester and Maltodextrin in people with Cardiogenic Shock, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (L/min) area under curve (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.