Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-29 @ 11:07 AM
Study NCT ID:
NCT03916861
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2019-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure during dialysis', 'timeFrame': 'During hemodialysis session start from enrollment until study completion, up to 4 hours', 'description': 'Blood pressure less than 20 mmHg from baseline ( systolic blood pressure)'}], 'secondaryOutcomes': [{'measure': 'Cardiac problem', 'timeFrame': 'Measure through study completion,for at least 3 months after randomization', 'description': 'Number of patients that have palpitation,cardiac arrthymia or chest pain'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Up to 3 months after enrollment', 'description': 'Total days in admission'}, {'measure': 'Percent of renal function', 'timeFrame': 'at least 3 months after enrollment', 'description': 'eGFR'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'BIA', 'Acute Kidney Injury'], 'conditions': ['Intradialytic Hypotension', 'Cardiac Event', 'Renal Insufficiency', 'Hospital Length of Stay']}, 'descriptionModule': {'briefSummary': 'This study was designed to compare the efficacy of BIA and physician adjustment to prevent intradialytic hypotension in patients with acute kidney injury who received renal replacement therapy. The investigators randomized 9 patients with acute kidney injury and volume overloaded who underwent acute hemodialysis for 45 sessions in Vajira hospital between October 2017 and February 2018. In physician adjust-group (control) estimate by physical examination and fluid balance record. Primary outcome was intradialytic hypotensive episode and secondary outcome was hemodialysis-related adverse events and other clinical outcome.', 'detailedDescription': 'Background\n\nVolume overload and intradialytic hypotension are significant complications with increasing mortality rate in hemodialysis patients. Bioelectrical Impedance Analysis (BIA) has been used to estimate the optimum weight in chronic hemodialysis patient to prevent intradialytic hypotension.Volume assessment in acute kidney injury is also of great importance , however, there are currently few methods to obtain an accurate assessment of hydration status in this scenario. This study was designed to compare the efficacy of BIA and physician adjustment to prevent intradialytic hypotension in patients with acute kidney injury who received renal replacement therapy.\n\nMethods\n\nThe investigators randomized 9 patients with acute kidney injury and volume overloaded who underwent acute hemodialysis for 45 sessions in Vajira hospital between October 2017 and February 2018. Volume overload was defined by BIA with value more than\\>0.4. In physician adjust-group (control) estimate by physical examination and fluid balance record. Primary outcome was intradialytic hypotensive episode and secondary outcome was hemodialysis-related adverse events and other clinical outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'More than 18 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute kidney injury with volume overload unresponsive to medication therapy =Required renal replacement therapy (RRT)\n\nExclusion Criteria:\n\nPatients who were pregnant\n\n* Advanced malignancy\n* Kidney transplantation\n* AKI from toxins\n* Currently on pacemaker\n* Had underlying chronic kidney disease\n* Patients with severe cardiovascular disease such as congestive heart failure, valvular regurgition'}, 'identificationModule': {'nctId': 'NCT03916861', 'briefTitle': 'BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bangkok Metropolitan Administration Medical College and Vajira Hospital'}, 'officialTitle': 'Bioelectrical Impedance Analysis Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy;Which One Can Help Reduce Intradialytic Hypotension', 'orgStudyIdInfo': {'id': '106/60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bioelectrical Impedance', 'description': 'The first group will be monitored by Inbody S20 analysis to measure fluid status. The Bioimpedance will be measured each time prior to hemodialysis session . The value of BIA measurement of more than 0.4 will be considered as edema.', 'interventionNames': ['Device: Bioelectrical Impedance Analysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physicain-guided group', 'description': 'The fluid monitoring will be managed by physician-adjustment by physical examination and fluid balance record . The fluid balance (FB) is the total fluid administered minus the total fluids eliminated over a period of time.', 'interventionNames': ['Procedure: Physician-guided']}], 'interventions': [{'name': 'Bioelectrical Impedance Analysis', 'type': 'DEVICE', 'description': 'We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.', 'armGroupLabels': ['Bioelectrical Impedance']}, {'name': 'Physician-guided', 'type': 'PROCEDURE', 'otherNames': ['Fluid balance record'], 'description': 'This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day', 'armGroupLabels': ['Physicain-guided group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10170', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Thananda Trakarnvanich', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Thananda Trakarnvanich', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vajira Hospital ,Navamindradhiraj University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangkok Metropolitan Administration Medical College and Vajira Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thananda Trakarnvanich', 'investigatorAffiliation': 'Bangkok Metropolitan Administration Medical College and Vajira Hospital'}}}}