Long-term, High Blood Flow Hemoadsorption Therapy in Patients Undergoing Maintenance Hemodialysis

Last updated: December 14, 2024
Sponsor: Dongliang Zhang, MD
Overall Status: Active - Enrolling

Phase

4

Condition

Hemodialysis

Treatment

long-term, high blood flow hemoadsorption therapy

Clinical Study ID

NCT06574425
K2024081208
  • Ages > 18
  • All Genders

Study Summary

Objective：The purpose of the study is to confirm that extending the duration of hemoadsorption (HA) and increasing blood flow during the HA+hemodialysis (HD) treatment process is safe and feasible, and to verify that extending the HP treatment duration can further increase the clearance of protein-bound uremic toxins.

Methods: The study employs a multicenter, prospective, cohort design with a self-controlled before-and-after comparison. The duration of HA+HD treatment for maintenance hemodialysis (MHD) patients is extended to 4 hours, and the extracorporeal blood flow rate is increased to over 250-350 ml/min. The safety of the treatment is assessed by evaluating the safety of the procedure; the levels of relevant toxins in the patients' blood are measured before and after treatment, and the clearance rate of uremic toxins after a single treatment is calculated and compared with the self-controlled before-and-after data to determine whether the modified protocol can remove more uremic toxins.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Maintenance Hemodialysis Patients with Uremia receive regular HA+HD treatment

Exclusion

Exclusion Criteria:

Plasma albumin <30g/L, severe malnutrition or cachectic state; platelet count <40×10^9/L or >300×10^9/L; hypercoagulable state allergy to the hemoperfusion device; new cardiovascular or cerebrovascular diseases; poor vascular access function, extracorporeal circulation blood flow unable to reach 250ml/min ultrafiltration volume >4500ml in a single dialysis session use of non-heparin anticoagulants inability to comply with the procedures of this study other conditions deemed unsuitable for participation in this study by the investigator

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: long-term, high blood flow hemoadsorption therapy
Phase: 4
Study Start date:
August 28, 2024
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Nephrology Department of Beijing Jishuitan Hospital

    Beijing, Beijing 100035
    China

    Site Not Available

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