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

NCT ID: NCT06574425

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-28

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Diseases Hemodialysis

Keywords

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protein-bound uremic toxins hemoadsorption

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients undergoing maintenance hemodialysis with once-weekly hemoadsorption

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.

Group Type EXPERIMENTAL

long-term, high blood flow hemoadsorption therapy

Intervention Type OTHER

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

Interventions

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long-term, high blood flow hemoadsorption therapy

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

Intervention Type OTHER

Eligibility Criteria

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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

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongliang Zhang, MD

OTHER

Sponsor Role lead

Responsible Party

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Dongliang Zhang, MD

Director of Nephrology Department of Beijing Jishuitan Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nephrology Department of Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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K2024081208

Identifier Type: -

Identifier Source: org_study_id