Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT01405092
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2011-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Versus Conventional Volume Management During CRRT (Continuous Renal Replacement Therapy)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compare number of hypotensive events in treatment versus control arms', 'timeFrame': '24 hour for each arm', 'description': 'compare the number of hypotensive events during use of crit-line monitor over 24 hour period versus during control 24 hour period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['volume', 'acute kidney injury', 'continuous renal replacement'], 'conditions': ['Continuous Renal Replacement Therapy']}, 'descriptionModule': {'briefSummary': 'Use of on-line blood volume monitoring during continuous renal replacement therapy can improve volume management in acute kidney injury patients requiring renal replacement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with kidney injury requiring continuous renal replacement therapy and volume removal\n\nExclusion Criteria:\n\n* unable to provide or obtain patient consent\n* not expected to survive 48 hours'}, 'identificationModule': {'nctId': 'NCT01405092', 'briefTitle': 'Continuous Versus Conventional Volume Management During CRRT (Continuous Renal Replacement Therapy)', 'organization': {'class': 'FED', 'fullName': 'Dallas VA Medical Center'}, 'orgStudyIdInfo': {'id': '#09-097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Standard volume management', 'description': 'patients on this arm will receive usual care volume management during continuous renal replacement therapy', 'interventionNames': ['Device: use of continuous renal replacement machine for renal replacement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'continuous volume management', 'description': 'use of Critline, Hemametrics USA, in conjunction with continuous renal replacment therapy to determine volume removal', 'interventionNames': ['Device: use of continuous renal replacement machine for renal replacement', 'Device: use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal']}], 'interventions': [{'name': 'use of continuous renal replacement machine for renal replacement', 'type': 'DEVICE', 'description': 'usual care with volume removal during continuous renal replacement therapy', 'armGroupLabels': ['Standard volume management', 'continuous volume management']}, {'name': 'use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal', 'type': 'DEVICE', 'description': 'blood volume monitoring device, Critline, Hemametric, USA, will be used in conjunction with continuous renal replacement to determine rate of volume removal', 'armGroupLabels': ['continuous volume management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dallas VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of In-center and Home Dialysis', 'investigatorFullName': 'Devasmita C. Dev MD', 'investigatorAffiliation': 'Dallas VA Medical Center'}}}}