Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:18 AM
Study NCT ID:
NCT07339202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hours from completion of the most recent preoperative hemodialysis session to entry into the operating room', 'timeFrame': 'up to 1 day'}, {'measure': 'Number of participants who experience electrolyte abnormalities or volume overload requiring additional unplanned hemodialysis, rescheduling / cancellation of the surgical procedure, or an unanticipated escalation of postoperative level of care.', 'timeFrame': 'up to 1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Management', 'End Stage Kidney Disease (ESRD)', 'Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '36326747', 'type': 'BACKGROUND', 'citation': 'Fielding-Singh V, Vanneman MW, Grogan T, Neelankavil JP, Winkelmayer WC, Chang TI, Liu VX, Lin E. Association Between Preoperative Hemodialysis Timing and Postoperative Mortality in Patients With End-stage Kidney Disease. JAMA. 2022 Nov 8;328(18):1837-1848. doi: 10.1001/jama.2022.19626.'}, {'pmid': '40504620', 'type': 'BACKGROUND', 'citation': 'Fielding-Singh V, Vanneman MW, Morris AM, Winkelmayer WC, Sun LY, Roshanov PS, Montez-Rath ME, Chertow GM, Lin E. Preoperative Dialysis Dose and Postoperative Outcomes in Patients Receiving Maintenance Hemodialysis. Kidney360. 2025 Nov 1;6(11):1948-1959. doi: 10.34067/KID.0000000874. Epub 2025 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the feasibility of two different preoperative hemodialysis schedules for people with end-stage kidney disease (ESKD) who undergo surgical procedures. The main questions it aims to answer are:\n\nIs it feasible to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis?\n\nIs it safe to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis?\n\nResearchers will compare the two hemodialysis schedules to see if the scheduling and safety profiles are the same.\n\nParticipants will:\n\nAnswer questions about their health up to 4 weeks before and 4 weeks after the surgical procedure.\n\nReceive hemodialysis on the day of the surgical procedure or not, depending on the study treatment assignment.', 'detailedDescription': 'Participants will participate in the study for approximately 2 months, including assessment of 30-day postoperative outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is willing to comply with all study procedures for the duration of the study\n2. Patient has a diagnosis of ESKD\n3. Patient initiated hemodialysis at least 90 days prior to the planned surgical procedure\n4. Patient is treated with a stable hemodialysis schedule, defined as an average of 2.5- 3.5 hemodialysis sessions per week in the preceding 4 weeks prior to surgery\n5. Patient is scheduled to undergo nonemergent surgical procedures in the Stanford Health Care system. This includes (but is not limited to):\n\n * Fistula or graft creation, revision, or removal\n * Fistulogram\n * Peritoneal dialysis catheter placement or revision\n * Lower extremity angiogram (including femoral and iliac vessels)\n * Lower extremity bypass (including femoral and iliac vessels)\n * Lower extremity amputation\n * Lower extremity endarterectomy (including femoral and iliac vessels) Of note, this list of procedures is not exhaustive and other procedures may be considered that meet inclusion criteria and no exclusion criteria, in consultation with the treatment teams involved.\n\nExclusion Criteria:\n\n1. Patient is pregnant\n2. Patient is a prisoner\n3. Patient is \\< 18 years old\n4. The treating clinicians determine that the patient's clinical condition necessitate a specific approach to surgical scheduling or preoperative hemodialysis"}, 'identificationModule': {'nctId': 'NCT07339202', 'acronym': 'POD-ESKD', 'briefTitle': 'Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial', 'orgStudyIdInfo': {'id': '69235'}, 'secondaryIdInfos': [{'id': '5K23DK138312-02', 'link': 'https://reporter.nih.gov/quickSearch/5K23DK138312-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Same-Day Hemodialysis', 'description': 'Participants will receive same-day hemodialysis, defined as a hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure (typically in the morning prior to the procedure).', 'interventionNames': ['Procedure: Same-Day Hemodialysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Same-Day Hemodialysis', 'description': 'Participants will not receive same-day hemodialysis, defined as a hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure.', 'interventionNames': ['Procedure: No Same-Day Hemodialysis']}], 'interventions': [{'name': 'Same-Day Hemodialysis', 'type': 'PROCEDURE', 'description': 'Hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure (typically in the morning prior to the procedure).', 'armGroupLabels': ['Same-Day Hemodialysis']}, {'name': 'No Same-Day Hemodialysis', 'type': 'PROCEDURE', 'description': 'No hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure.', 'armGroupLabels': ['No Same-Day Hemodialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Rahul Deshmane', 'role': 'CONTACT'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Vikram Fielding-Singh, MD, JD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor, Department of Anesthesiology', 'investigatorFullName': 'Vikram Fielding-Singh', 'investigatorAffiliation': 'Stanford University'}}}}