Benefits of Hemodialysis Plus Hemoperfusion: A Clinical Study

Launched by CHANGHAI HOSPITAL · Nov 25, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the benefits of combining two treatments—hemodialysis (HD) and hemoperfusion (HP)—for patients with end-stage renal disease (kidney failure). The researchers want to see if this combination can help remove certain harmful substances from the blood more effectively than hemodialysis alone. If you're an adult aged between 18 and 80, have been on regular hemodialysis for at least three months, and have specific levels of certain blood markers, you might be eligible to participate in this study.

Participants will receive treatment as part of the trial and will be monitored to see how well the combination therapy works. This study is currently recruiting participants, and it’s important to note that certain health conditions and recent medical events may prevent someone from joining. If you're considering participating or want to learn more, be sure to discuss it with your healthcare provider to see if it’s a good fit for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-80 years, regardless of gender
• • 2. Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysis pattern
• • 3. Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours per week, vascular access unlimited
• • 4. Blood β2-MG \> 30 mg/L and/or 300 pg/ml \< immunoreactive parathyroid hormone (iPTH) \< 800 pg/ml and/or CRP ≥ 16.2 pg/ml
• • 5. Kt/V ≥ 1.2 eight weeks prior to enrollment
• • 6. Signed informed consent form
• Exclusion Criteria:
• • 1. Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus
• • 2. Test 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/L
• • 3. Blood flow \<200 ml/min
• • 4. Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks
• • 5. Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders
• • 6. History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks
• • 7. Cerebral hemorrhage in the last 12 weeks
• • 8. Severe heart failure (New York Heart Association class IV)
• • 9. Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancy
• • 10. Pregnancy or breastfeeding
• • 11. Participation in a clinical trial or ongoing clinical trial within 3 months
• • 12. Expected survival of less than 1 year
• • 13. Not considered suitable for participation in this trial by the investigator

Trial Officials