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Recruiting
NCT05639010
Benefits of Hemodialysis Plus Hemoperfusion: A Clinical Study
Conditions: End Stage Renal Disease
Sex: All
Ages: 18 Years – 80 Years
Phase: NA
Enrollment: 410
Sponsor: Changhai Hospital
Location: China
Summary
This multi-center, open-label, randomized, parallel controlled trial aims to investigate the efficacy of hemoperfusion (HP) in combination with hemodialysis (HD) by assessing blood β2-microglobulin (β2-MG), parathyroid hormone (PTH) and C reactive protein (CRP) clearance in maintenance hemodialysis patients.
Eligibility Criteria
Inclusion Criteria:Age 18-80 years, regardless of genderStable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysis patternHemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours per week, vascular access unlimitedBlood β2-MG > 30 mg/L and/or 300 pg/ml < immunoreactive parathyroid hormone (iPTH) < 800 pg/ml and/or CRP ≥ 16.2 pg/mlKt/V ≥ 1.2 eight weeks prior to enrollmentSigned informed consent formExclusion Criteria:Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatusTest indicators meeting one or more of the following: white blood cell <4 x 10^9/L, platelet count <60 x 10^9/L, serum albumin <30 g/LBlood flow <200 ml/minRegular hemoperfusion treatment for more than 3 months and at least once every 2 weeksActive bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disordersHistory of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeksCerebral hemorrhage in the last 12 weeksSevere heart failure (New York Heart Association class IV)Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancyPregnancy or breastfeedingParticipation in a clinical trial or ongoing clinical trial within 3 monthsExpected survival of less than 1 yearNot considered suitable for participation in this trial by the investigator
Source: ClinicalTrials.gov (NCT05639010). StuddyBuddy aggregates publicly available trial information.