Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT03431194
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2018-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury
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': 'D008879', 'term': 'Midodrine'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hypotensive episodes', 'timeFrame': '30 days from start of hemodialysis', 'description': 'Number of hypotensive episodes'}], 'secondaryOutcomes': [{'measure': 'mean systolic blood pressure', 'timeFrame': '30 days from start of hemodialysis', 'description': 'compare mean systolic blood pressure between the two arms'}, {'measure': 'mean diastolic blood pressure', 'timeFrame': '30 days from start of hemodialysis', 'description': 'compare mean diastolic blood pressure between the two arms'}, {'measure': 'Mortality in each arm', 'timeFrame': '30 days from start of hemodialysis', 'description': 'Number of dead patients in each arm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'midodrine', 'intensive care unit'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the management of intradialytic hypotension among critically ill patients with acute kidney injury.', 'detailedDescription': 'In This open -label study, patients in ICU with acute kidney injury are randomized to either midodrine tablets or placebo. the number of intradialytic episodes and both systolic and diastolic blood pressure between both groups are compared. Mortality and adverse effects are monitored and compared as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients\n* acute kidney injury\n* age above 18 years\n* documented hypotension during dialysis\n\nExclusion Criteria:\n\n* packed red blood cells transfusion\n* intravenous inotropes\n* alteration of blood pressure medications'}, 'identificationModule': {'nctId': 'NCT03431194', 'briefTitle': 'Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'BN-14716'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'midodrine group', 'description': 'Patients will receive midodrine tablets', 'interventionNames': ['Drug: midodrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'Patients receive sugary oral tablets therapy', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'midodrine', 'type': 'DRUG', 'description': 'oral midodrine tablets 5 mg', 'armGroupLabels': ['midodrine group']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New Jeddah Clinic Hospital', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Internal Medicine', 'investigatorFullName': 'Mahmoud Hamada imam', 'investigatorAffiliation': 'Benha University'}}}}