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

NCT06574425 | Enrolling By Invitation Phase 4

• 1 other identifier: K2024081208
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Hemodialysis

Keywords

protein-bound uremic toxins; hemoadsorption

Outcome Measures

Primary Outcomes (1)

• protein-bound toxins

  the clearance of protein-bound toxins will change

  1month

Study Arms (1)

Patients undergoing maintenance hemodialysis with once-weekly hemoadsorption

EXPERIMENTAL

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

Interventions

long-term, high blood flow hemoadsorption therapy 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

Patients undergoing maintenance hemodialysis with once-weekly hemoadsorption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maintenance Hemodialysis Patients with Uremia receive regular HA+HD treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Dongliang Zhang, MD: lead

Study Sites (1)

Nephrology Department of Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Nephrology Department of Beijing Jishuitan Hospital

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: August 28, 2024
• Primary Completion: May 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

CN (1)