Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-03-05 @ 12:49 AM
Study NCT ID:
NCT03078504
Status:
TERMINATED
Last Update Posted:
2020-03-30
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zafar.jamkhana@health.slu.edu', 'phone': '314-577-8856', 'title': 'Dr.Zafar Jamkhana', 'organization': 'Saint Louis University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '40 minutes', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Arm', 'description': 'The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics\n\ncontinuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Pressure Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics\n\ncontinuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Change in mean arterial pressure from period 1 to period 2', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Arm', 'description': 'The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics\n\ncontinuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Arm', 'description': 'The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics\n\ncontinuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'mean arterial pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '79', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-20', 'size': 182200, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-24T11:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Failure to recruit patients further', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'dispFirstSubmitDate': '2020-01-03', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2017-03-08', 'dispFirstSubmitQcDate': '2020-03-27', 'resultsFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2017-03-08', 'dispFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-27', 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure Change', 'timeFrame': '10 minutes', 'description': 'Change in mean arterial pressure from period 1 to period 2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'End-stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-89\n* Acute renal failure or end-stage renal disease necessitating CRRT\n* Admitted to the MICU service\n* If on vasopressor/inotropic agent, norepinephrine as only intravenous pressor\n* If on vasopressor/inotropic agent, at stable pressor dose for at least four hours\n* If on IV fluids, stable dose of crystalloids \\<= 100cc/hour and is not receiving colloids for 4 hours or more prior to initiation of CRRT\n* Mean arterial pressure (MAP) \\>= 65\n* Arterial catheter present for continuous blood pressure monitoring\n* CRRT duration of 48 hours or less using NxStage System One dialysis system\n* successfully tolerated CRRT for at least 4 hours without clotting or hemodynamic instability\n* no other procedures, blood products transfusion, or additional medication administration are anticipated during the study period\n\nExclusion Criteria:\n\n* listed for organ transplant\n* atrial fibrillation, other irregular heart rhythm, unstable arrhythmia\n* need for more than one intravenous vasopressor agent\n* intravenous vasopressor/inotropic agent other than norepinephrine (ie dobutamine, dopamine, vasopressin, epinephrine)\n* therapeutic anticoagulation being administered\n* known acute myocardial infarction as defined by elevated troponin along with a documented clinical diagnosis during current hospitalization\n* known acute stroke, intracerebral hemorrhage, intracranial mass effect, or elevated intracranial pressure within the last 30 days.\n* dialysis catheter malfunction and unable to maintain target blood flow rate\n* fluid removal (ultrafiltration) rate \\> 100mL/hour'}, 'identificationModule': {'nctId': 'NCT03078504', 'briefTitle': 'Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'St. Louis University'}, 'officialTitle': 'Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy', 'orgStudyIdInfo': {'id': '26817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics', 'interventionNames': ['Device: continuous renal replacement therapy using System One (TM) setup (Nxstage)']}], 'interventions': [{'name': 'continuous renal replacement therapy using System One (TM) setup (Nxstage)', 'type': 'DEVICE', 'otherNames': ['NxStage'], 'description': 'Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Zafar Jamkhana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Louis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zafar Jamkhana, MD', 'investigatorAffiliation': 'St. Louis University'}}}}