Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-01-04 @ 1:38 PM
Study NCT ID:
NCT00666003
Status:
COMPLETED
Last Update Posted:
2011-02-08
First Post:
2008-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Assessment APCO Monitor vs Crit Line for Renal Replacement Rx
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-07', 'studyFirstSubmitDate': '2008-04-23', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodynamics'], 'conditions': ['Renal Failure', 'Hemodynamics']}, 'descriptionModule': {'briefSummary': 'Fluid and volume management are a challenging part of critical care and the difficulties increase in the face of renal failure. Utilizing the Crit-Line to monitor blood volume changes in conjunction with arterial pressure cardiac output monitoring may lead to better understanding of the impact fluid removal during dialysis has on hemodynamics.', 'detailedDescription': 'Patients in an ICU often require large amounts of IV fluid to maintain adequate cardiac function. In patients with renal failure, the ability to gauge adequacy of circulating blood volume based on urine output is obviously lacking. The FDA approved devices called Flotrac/Vigileo and Crit-Line are used in this setting to determine adequacy of fluid resuscitation. This study proposes to use the data collected in a retrospective manner to determine if correlation of the various measured parameters can serve as a predictor of hemodynamic status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Renal Failure Patients in the ICU', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indwelling arterial catheter\n* Require dialysis\n* CVP in place\n* Use of Crit-Line and Flotrak device\n\nExclusion Criteria:\n\n* Aortic Regurgitation\n* Use of an intra-aortic balloon pump\n* Weight less than 90 lbs\n* Cardiac arrhythmias'}, 'identificationModule': {'nctId': 'NCT00666003', 'acronym': 'APCOvC-Line', 'briefTitle': 'Hemodynamic Assessment APCO Monitor vs Crit Line for Renal Replacement Rx', 'organization': {'class': 'OTHER', 'fullName': 'Baystate Medical Center'}, 'officialTitle': 'Hemodynamic Assessment Comparison Between Arterial Pressure Cardiac Output Monitor and Crit Line Utilized During Renal Replacement Therapy', 'orgStudyIdInfo': {'id': 'IRB07-120'}}, 'contactsLocationsModule': {'locations': [{'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}], 'overallOfficials': [{'name': 'Patrick Mailloux, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baystate Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baystate Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Patrick T. Mailloux, DO', 'oldOrganization': 'Baystate Medical Cetner'}}}}