Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 5:33 AM
Study NCT ID:
NCT04602767
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2020-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2020-10-20', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with acute kidney injury', 'timeFrame': '5 Days', 'description': 'KDIGO criteria'}], 'secondaryOutcomes': [{'measure': 'Number of patients with 30-Day Mortality', 'timeFrame': '30 Days', 'description': 'Number of patients with 30-Day Mortality'}, {'measure': 'Number of patients with reoperation', 'timeFrame': '5 Days', 'description': 'Number of patients with reoperation'}, {'measure': 'Number of patients with sternal Infection', 'timeFrame': '5 Days', 'description': 'Number of patients with sternal Infection'}, {'measure': 'Number of patients with Atrial Fibrilation', 'timeFrame': '5 Days', 'description': 'Number of patients with Atrial Fibrilation'}, {'measure': 'ICU Length of Stay', 'timeFrame': '5 Days', 'description': 'Total ICU Length of Stay'}, {'measure': 'Total Vasopressor Hours', 'timeFrame': '5 Days', 'description': 'Total Vasopressor Hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open label study to investigate vasopressin versus phenylephrine as a first line pressor in cardiac surgery. All patients \\>18 years of age presenting for coronary artery bypass graft (CABG), valve surgery, or combined CABG and valve surgery will be screened for inclusion. Patients with ejection fraction \\< 35%, \\> moderate pulmonary hypertension, \\> mild right ventricular dysfunction, a planned radial arterial graft, or circulatory arrest will be excluded. Patients will be randomized to receive either vasopressin or phenylephrine as the first line vasopressor during the perioperative period to maintain mean arterial blood pressure \\>65 mmhg. Primary outcome is acute kidney injury. Secondary outcomes are 30-day mortality, stroke, myocardial infarction, re-operation, sternal infection, atrial fibrillation, intensive care unit length of stay, and total vasopressor hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years of age\n* Coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery\n\nExclusion Criteria:\n\n* Ejection fraction \\< 35%\n* \\> moderate pulmonary hypertension\n* \\> mild right ventricular dysfunction\n* Radial arterial graft\n* Circulatory arrest'}, 'identificationModule': {'nctId': 'NCT04602767', 'briefTitle': 'Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery', 'orgStudyIdInfo': {'id': '20D.847'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vasopressin', 'description': 'Low dose vasopressin as first line vasopressor in cardiac surgery.', 'interventionNames': ['Drug: Vasopressin']}, {'type': 'EXPERIMENTAL', 'label': 'Phenylephrine', 'description': 'Low dose phenylephrine as first line vasopressor in cardiac surgery', 'interventionNames': ['Drug: Phenylephrine']}], 'interventions': [{'name': 'Vasopressin', 'type': 'DRUG', 'otherNames': ['Pitressin'], 'description': 'Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP \\< 65 mmHg', 'armGroupLabels': ['Vasopressin']}, {'name': 'Phenylephrine', 'type': 'DRUG', 'otherNames': ['Neosynephrine'], 'description': 'Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP \\< 65 mmHg', 'armGroupLabels': ['Phenylephrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jordan Goldhammer, MD', 'role': 'CONTACT', 'email': 'jordan.goldhammer@jefferson.edu'}], 'facility': 'Thomas Jefferson Univesity', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Jenifer Lessin', 'role': 'CONTACT', 'email': 'jennifer.lessin@jefferson.edu', 'phone': '215 955-5804'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology', 'investigatorFullName': 'Jordan Goldhammer', 'investigatorAffiliation': 'Thomas Jefferson University'}}}}