Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:14 AM
Study NCT ID:
NCT07428395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Intradialytic Monitoring During CKRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D051436', 'term': 'Renal Insufficiency, 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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy (% deviation) of hematocrit measured by CLM (Hct CLM) and hematocrit as measured by complete blood count (Hct CBC).', 'timeFrame': '48-hour dialysis treatment'}], 'secondaryOutcomes': [{'measure': 'Accuracy (% deviation) oxygen saturated measured by CLM (SpO2 CLM) and oxygen saturation as measured by complete blood count (SpO2 VBG)', 'timeFrame': '48-hour dialysis treatment'}, {'measure': 'Time of patency of the NxStage-CritLine cartridge/filter system', 'timeFrame': '48-hour dialysis treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'End Stage Chronic Renal Failure', 'Dialysis']}, 'descriptionModule': {'briefSummary': 'This is a pilot observational cohort study to understand whether advanced monitoring techniques can be applied during continuous kidney replacement therapy (CKRT), which is the most common form of dialytic therapy provided in critically ill patients.', 'detailedDescription': 'The CritLine-IV® monitor is a non-invasive device which integrates into the dialysis circuitry to continuous provide hematocrit and oxygen saturation values during dialysis. This monitoring has been used both in clinical and research settings with good accuracy over 4 hours of hemodialysis and has been used to guide real-time decisions on fluid management during intermittent hemodialysis. Given its non-invasive application, continuous measurements, and ease of integration into the dialysis circuitry, this technology has great potential for use in the critical care setting, where changes in clinical status and acuity of illness often require frequent reassessment and adjustment of dialysis settings. However, the reliability of Critline-IV® measurements over longer periods of time is unknown. In this study, we intend to determine the accuracy over time of Critline-IV® monitoring during CKRT, establish whether it impacts CKRT performance (primarily dialysis filter patency), and explore potential signal changes during various interventions commonly performed in the intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to one of the Medical ICUs and the Cardiothoracic ICU who have been prescribed CKRT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have been admitted to the Medical ICU or Cardiothoracic ICU at the Hospital of the University of Pennsylvania (HUP).\n2. Patients who have been prescribed continuous venovenous hemodialysis (CVVHD) or Continuous Veno-Venous Hemofiltration (CVVH), the predominant modalities of continuous kidney replacement therapy (CKRT) at HUP.\n3. Patients who have central venous catheters placed in either the left or right internal jugular veins.\n\nExclusion Criteria:\n\n1. Patients who are prescribed other forms of CKRT, namely continuous venovenous hemofiltration (CVVH), slow continuous ultrafiltration (SCUF), or prolonged intermittent kidney replacement therapy (PIKRT).\n2. Patients who have femoral vein dialysis catheters placed.\n3. Patients who cannot provide consent or have a legal proxy to provide consent.'}, 'identificationModule': {'nctId': 'NCT07428395', 'briefTitle': 'Feasibility of Intradialytic Monitoring During CKRT', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Feasibility of Intradialytic Hematocrit and Oxygen Saturation Monitoring During Continuous Kidney Replacement Therapy', 'orgStudyIdInfo': {'id': '855545'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Christina Brotman, MD, MSCE', 'role': 'CONTACT', 'email': 'Christina.Brotman@pennmedicine.upenn.edu', 'phone': '2156622638'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christina Brotman', 'investigatorAffiliation': 'University of Pennsylvania'}}}}