Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-29 @ 3:39 PM
Study NCT ID:
NCT04642768
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2020-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output (L/min) area under curve', 'timeFrame': '3 hours', 'description': 'Right Heart Catheterization (by thermodilution)'}], 'secondaryOutcomes': [{'measure': 'Cardiac output (L/min)', 'timeFrame': '1 hour', 'description': 'Right Heart Catheterization (by thermodilution)'}, {'measure': 'Left Ventricular Filling Pressure (mmHg) area under curve', 'timeFrame': '3 hours', 'description': 'Right Heart Catheterization'}, {'measure': 'Cardiac Power Output (W) area under curve', 'timeFrame': '3 hours', 'description': 'mean arterial pressure x cardiac output/451'}, {'measure': 'Mixed Venous Saturation (%) area under curve', 'timeFrame': '3 hours', 'description': 'Right Heart Catheterization'}, {'measure': 'Left Ventricular Ejection Fraction (%) area under curve', 'timeFrame': '3 hours', 'description': 'Echocardiography'}, {'measure': 'Hourly urinary output (mL/hour) area under curve', 'timeFrame': '3 hours'}, {'measure': 'Renal Perfusion (mL/min)', 'timeFrame': '1 hours', 'description': 'Renal doppler ultrasound'}, {'measure': 'Arterial Lactate (mmol/L) area under curve', 'timeFrame': '3 hours', 'description': 'Arterial blood gas measurements'}, {'measure': 'Cumulative doses of inotropes and vasopressors during the 3 hour studyperiod', 'timeFrame': '3 hours'}, {'measure': 'Cerebral Perfusion area under curve', 'timeFrame': '3 hours', 'description': 'Near-infrared spectroscopy'}, {'measure': 'Peripheral Perfusion area under curve', 'timeFrame': '3 hours', 'description': 'Near-infrared spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketone bodies', 'β-hydroxybutyrate'], 'conditions': ['Cardiogenic Shock']}, 'referencesModule': {'references': [{'pmid': '37452805', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nObjective 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.\n\nDesign A randomized double-blind cross-over study of the hemodynamic effect of enteral ketone ester versus placebo in 12 patients with cardiogenic shock\n\nMethods 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.\n\nPerspectives 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ongoing treatment with inotropes and/or vasopressors because of cardiogenic shock as judged by the clinicians\n* 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)\n* LVEF \\< 40%\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Other primary causes of shock (hypovolemia, hemorrhage, severe infection or sepsis, pulmonary embolism or anaphylaxis),\n* Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall)\n* INTERMACS level 1 or 2 \\[18\\] with unstable or sliding hemodynamics on inotropes/vasopressors\n* Use of or probable need for mechanic circulatory support (e.g. left ventricular assistant device, IMPELLA, extracorporeal membrane oxygenation)\n* Recent post-cardiotomy cardiogenic shock (defined as thoracic surgery with the last 3 days)\n* Inability to position a nasogastric tube\n* Severe gastroparesis or abdominal distension'}, 'identificationModule': {'nctId': 'NCT04642768', 'acronym': 'KETO-SHOCK1', 'briefTitle': 'Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock', 'orgStudyIdInfo': {'id': 'KETO-SHOCK 1-10-72-209-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3-Hydroxybutyrate treatment', 'description': 'KetoneAid Ketone Ester 0,5g/kg (max. 50g) bolus', 'interventionNames': ['Dietary Supplement: KetoneAid Ketone Ester']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Treatment', 'description': 'Maltodextrin-base isocaloric placebo', 'interventionNames': ['Dietary Supplement: Maltodextrin']}], 'interventions': [{'name': 'KetoneAid Ketone Ester', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Commercially available ketone supplement', 'armGroupLabels': ['3-Hydroxybutyrate treatment']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Commercially available maltodextrin supplement', 'armGroupLabels': ['Placebo Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kristoffer Berg-Hansen', 'investigatorAffiliation': 'University of Aarhus'}}}}