Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-02-05 @ 2:32 PM
Study NCT ID:
NCT06981559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study on the Impact of Hemoperfusion on the Prognosis of Uremic Patients Undergoing Maintenance Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with MCI as assessed by Montreal Cognitive Assessmen', 'timeFrame': 'month 12 and month 36', 'description': 'Montreal Cognitive Assessment: A score of 24 or higher is considered normal, while a score below 24 may indicate mild cognitive impairment(MCI）'}, {'measure': 'Number of participants with cardiovascular events according to ACC/AHA guideline', 'timeFrame': 'month 12 and month 36', 'description': 'Number of participants with cardiovascular events including myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death'}, {'measure': 'Number of participants with Sarcopenia as assessed by using BIA', 'timeFrame': 'month 12 and month 36', 'description': 'ASMI (kg/m2) will be calculated as ASM(kg)/height 2（m2). ASM will be measured using bioimpedance analysis (BIA)'}], 'secondaryOutcomes': [{'measure': 'Toxin removal efficiency', 'timeFrame': 'month 12 and month 36', 'description': 'Decline rate of β2-MG from baseline level'}, {'measure': 'Solute removal efficiency', 'timeFrame': 'month 12 and month 36', 'description': 'spKt/V'}, {'measure': 'Toxin removal efficiency', 'timeFrame': 'month 12 and month 36', 'description': 'Decline rate of IL-6 from baseline level'}, {'measure': 'Toxin removal efficiency', 'timeFrame': 'month 12 and month 36', 'description': 'Decline rate of proteomics and metabolomics from baseline levels'}, {'measure': 'Solute removal efficiency', 'timeFrame': 'month 12 and month 36', 'description': 'URR'}, {'measure': 'Solute removal efficiency', 'timeFrame': 'month 12 and month 36', 'description': 'electrolytes (potassium)'}, {'measure': 'Solute removal efficiency', 'timeFrame': 'month 12 and month 36', 'description': 'electrolytes (sodium)'}, {'measure': 'Solute removal efficiency', 'timeFrame': 'month 12 and month 36', 'description': 'electrolytes (calcium)'}, {'measure': 'Solute removal efficiency', 'timeFrame': 'month 12 and month 36', 'description': 'electrolytes (phosphorus)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The goal of this real-world clinical trial study is to evaluate the impact of hemoperfusion on the prognosis of patients with End-Stage Renal Disease (ESRD) undergoing maintenance hemodialysis.', 'detailedDescription': 'The investigators are planning to conduct a real-world clinical trial study, enrolling patients with maintenance hemodialysis (MHD) from Huashan Hospital. Patients will be divided into two groups based on their hemoperfusion (HP) treatment frequency: high-frequency HP treatment group (≥1 session every 2 weeks) and low-frequency HP treatment group (\\<1 session every 2 weeks). The investigators will collect baseline demographic data, cardiovascular events, cognitive function status, and nutrition-related clinical indicators for both groups. After a 3-year follow-up, The investigators will reassess these parameters to explore the impact of HP on the prognosis of MHD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be divided into two groups based on the frequency of hemoperfusion treatments they receive: the high-frequency hemoperfusion group (≥1 session every 2 weeks) and the low-frequency hemoperfusion group (\\<1 session every 2 weeks).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing maintenance hemodialysis for ≥3 months Aged ≥18 years and \\<85 years; Regular hemodialysis treatment, 3 times per week No residual renal function (urine output \\<200 mL/d); Written informed consent has been obtained from the participant.\n\nExclusion Criteria:\n\nPatients with severe cerebrovascular diseases (new-onset cerebral infarction, cerebral hemorrhage) or neurological diseases (autoimmune encephalitis, epilepsy, neurodevelopmental disorders).\n\nPatients with acute severe infections (such as sepsis), severe cardiopulmonary insufficiency (NYHA class IV heart failure, acute exacerbation of COPD), or malignancies.\n\nPatients receiving combined hemodialysis and peritoneal dialysis treatment. Patients with allergic reactions, contraindications, or intolerance to dialysis membrane materials.\n\nPatients with a platelet count \\<60 × 10\\^9/L. Other conditions deemed by the investigators as unsuitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06981559', 'briefTitle': 'A Clinical Study on the Impact of Hemoperfusion on the Prognosis of Uremic Patients Undergoing Maintenance Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'A Clinical Study on the Impact of Hemoperfusion on the Prognosis of Uremic Patients Undergoing Maintenance Hemodialysis', 'orgStudyIdInfo': {'id': 'KY2024-1356'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high-frequency hemoperfusion group', 'description': '≥1 session every 2 weeks'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'xujiao chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'xujiao chen', 'investigatorAffiliation': 'Huashan Hospital'}}}}