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

Dongliang Zhang, MD

Status and phase: Invitation-only; Phase 4

Conditions: Chronic Kidney Diseases; Hemodialysis

Treatments: Other: long-term, high blood flow hemoadsorption therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06574425

K2024081208

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Maintenance Hemodialysis Patients with Uremia receive regular HA+HD treatment

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Patients undergoing maintenance hemodialysis with once-weekly hemoadsorption

Experimental group

Description:

The blood flow rate is based on the actual blood flow speed displayed by the dialysis machine; the dialysis fluid flow rate is 500 ml/min; the total ultrafiltration volume in 4 hours does not exceed 4500 ml.All subjects undergo a self-controlled before-and-after comparison, with continuous 3 weeks of HA+HD treatment, once a week. The HA+HD treatment is implemented at a short interval of 1 day after the previous dialysis treatment. Group 1 is the routine treatment group, Group 2 is the extended time group, and Group 3 is the extended time and increased blood flow group, also known as the modified HA+HD group. The treatment modes of the three groups are implemented sequentially in order.

Treatment:

Other: long-term, high blood flow hemoadsorption therapy