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

December 14, 2024 updated by: Dongliang Zhang, MD

A Multicenter, Prospective, Cohort Study on the Safety and Efficacy of Long-term, High Blood Flow Hemoadsorption Therapy in Patients Undergoing Maintenance Hemodialysis

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100035
        • Nephrology Department of Beijing Jishuitan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
protein-bound toxins
Time Frame: 1month
the clearance of protein-bound toxins will change
1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongliang Zhang, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

August 25, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 14, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2024081208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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