Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-27 @ 2:53 PM
Study NCT ID:
NCT06713668
Status:
RECRUITING
Last Update Posted:
2025-05-02
First Post:
2024-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmented Pacing for Shock in the Cardiac Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D012769', 'term': 'Shock'}], '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': 'D001145', 'term': 'Arrhythmias, Cardiac'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-04-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2024-11-01', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Index by thermodilution', 'timeFrame': 'At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes)', 'description': 'Cardiac Index measured by thermodilution (in liters per minute per meters squared)'}], 'secondaryOutcomes': [{'measure': 'Cardiac Index by Indirect Fick', 'timeFrame': '0, 15, 30 minutes.'}, {'measure': 'Cardiac Output by thermodilution', 'timeFrame': '0, 15, 30 minutes.'}, {'measure': 'Cardiac Output by indirect fick', 'timeFrame': '0 ,15, 30 minutes'}, {'measure': 'Central Venous Pressure', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Pulmonary Artery Systolic Pressure', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Pulmonary Artery Diastolic Pressure', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Pulmonary Artery Pulsitility Index', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Right Ventricular Stroke Work Index', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Pulmonary Artery (Mixed Venous) Blood Hemoglobin saturation', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Cardiac Power Index (Thermodilution and indirect fick)', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Cardiac Power Output (Thermodilution and indirect fick)', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Systolic Blood pressure', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Difference in vasopressor/inotrope requirements', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Arrhythmia events (Atrial and Ventricular)', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Percentage of PVCs', 'timeFrame': '0, 15, 30 minutes'}, {'measure': 'Pacing percentage (Atrial, RV or Bi-V)', 'timeFrame': '0, 15, 30 minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cardiogenic Shock', 'Bradycardia', 'Shock', 'Pacing'], 'conditions': ['Cardiogenic Shock', 'Bradycardia', 'Shock']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. The main question it aims to answer is:\n\nDoes increasing the backup pacing rate to 100 beats per minute lead to improved cardiac index compared to a backup pacing rate of 75 beats per minute\n\nParticipants who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker and pulmonary artery catheter in place will be enrolled in this study. Participants will be exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age 18 and older)\n* Located in the CVICU\n* FDA approved permanent pacemaker in place (inclusive of dual-chamber and Bi-Ventricular ICDs) with labeling that allows backup pacing setting at 100 bpm.\n* Receiving a vasopressor or Inotrope for at least 4 hours\n* Average HR ≤ 75 bpm over the last hour (on Telemetry review)\n* Pulmonary artery catheter in place with functioning thermistor and pulmonary artery port.\n\nExclusion Criteria:\n\n* Single chamber Implantable Cardiac Defibrillator\n* Sinus rhythm with a leadless pacemaker\n* Ventricular Tachycardia or Ventricular Fibrillation arrest in last 48 hours\n* Hemodynamic instability within the last 4 hours, defined as an increase in the dose of norepinephrine \\> 10 mcg/min, an increase of epinephrine \\> 10 mcg/kg/min, or initiation of a second vasopressor\n* Alternative indication for pacing rate change (i.e Torsade de Pointes, Recurrent Ventricular Tachycardia)\n* Comfort-focused care or anticipated death within 24 hours\n* Mechanical circulatory support in place\n* Newly discovered pacing system malfunction (lead displacement, loss of capture, elevated capture threshold, significant lead impedance change, battery depletion, undersensing or oversensing)\n* Non-English Speaking'}, 'identificationModule': {'nctId': 'NCT06713668', 'briefTitle': 'Augmented Pacing for Shock in the Cardiac Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial', 'orgStudyIdInfo': {'id': '241410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Pacing (75 bpm) then Augmented Pacing (100 bpm)', 'description': 'Backup pacing rate will be set to 75 bpm first then 100 bpm second', 'interventionNames': ['Device: Backup Pacing Rate Change']}, {'type': 'OTHER', 'label': 'Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm)', 'description': 'Backup pacing rate will be set to 100 bpm first then 75 bpm second', 'interventionNames': ['Device: Backup Pacing Rate Change']}], 'interventions': [{'name': 'Backup Pacing Rate Change', 'type': 'DEVICE', 'description': 'Patients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A', 'armGroupLabels': ['Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm)', 'Standard Pacing (75 bpm) then Augmented Pacing (100 bpm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonah D Garry, MD', 'role': 'CONTACT', 'email': 'jonah.garry@vumc.org', 'phone': '914-523-3933'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Jonah D Garry, M.D', 'role': 'CONTACT', 'email': 'jonah.garry@vumc.org', 'phone': '914-523-3933'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiovascular Medicine Research Fellow', 'investigatorFullName': 'JGarry', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}