Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 9:00 PM
Study NCT ID:
NCT07360769
Status:
COMPLETED
Last Update Posted:
2026-01-22
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Hemodialysis: How Low Dialysate Flow Alters Adequacy and Patient Recovery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-17', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of dialysate flow rate, for three successive conventional hemodialysis sessions, from 500ml/min to 300ml/min and its impact on hemodialysis adequacy that is assessed by urea reduction ratio (URR).', 'timeFrame': 'Two weeks'}, {'measure': 'The change of dialysate flow rate, for three successive conventional hemodialysis sessions, from 500ml/min to 300ml/min and its impact on hemodialysis adequacy that is assessed by and single-pool Kt/V (spKt/V) using the Daugirdas formula.', 'timeFrame': 'Two weeks'}], 'secondaryOutcomes': [{'measure': 'The effect of lowering dialysate flow rate from 500ml/min (milli per minute) to 300ml/min on dialysis recovery time (DRT) in minutes. Longer duration indicates lower dialysis adequacy.', 'timeFrame': 'two weeks'}, {'measure': 'The patients reported outcome measures that is assessed by palliative care Outcome Scale - Symptoms Renal (POS S renal). Each symptom takes a score from zero to four (0-4), high score indicates less efficient dialysis.', 'timeFrame': 'Tow weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Kidney Disease (ESRD)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to detect if lower dialysate flow rate can affect hemodialysis adequacy , dialysis recovery time and patients quality of life.\n\nThe main questions it aims to answer are:\n\ndoes low dialysate flow affect hemodialysis adequacy? does green dialysis achievable without affecting hemodialysis adequacy? Researchers will compare hemodialysis session of high dialysate flow to that with low dialysate flow.\n\nParticipants will:\n\nunderwent hemodialysis for a week with low dialysate flow and another week with high dialysate flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ESKD patients more than or equal 18 years old, on maintenance HD thrice weekly for more than three months and each session lasts for 4 hours.\n* All patients will receive HD via an arterio-venous fistula.\n* All patients will receive HD via the same type of HD machine and the blood pump will be set at 300ml/min.\n* All patients will receive the same type of HD membranes and every effort will be made to achieve the dry weight of the patients.\n\nExclusion Criteria :\n\n* Critically ill and hospitalized ESKD patients.\n* Mentally disabled patients.\n* Patients with terminal malignancy or receiving chemotherapy.\n* Patients receiving immune suppression treatment.'}, 'identificationModule': {'nctId': 'NCT07360769', 'briefTitle': 'Optimizing Hemodialysis: How Low Dialysate Flow Alters Adequacy and Patient Recovery.', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Low Dialysate Flow: Its Effect on Hemodialysis Adequacy, Dialysis Recovery Time and Patient Reported Outcome Measures.', 'orgStudyIdInfo': {'id': '0108861'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESKD patients', 'interventionNames': ['Other: lower dialysate flow rate ( 300ml/min). then testing its effect on hemodialysis adequacy']}], 'interventions': [{'name': 'lower dialysate flow rate ( 300ml/min). then testing its effect on hemodialysis adequacy', 'type': 'OTHER', 'description': 'The aim of this study is to check whether change of dialysate flow from 500ml/min to 300ml/min has a significant impact on dialysis adequacy , dialysis recovery time and patient reported outcome measures in maintenance hemodialysis patients.', 'armGroupLabels': ['ESKD patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Medicine Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}