The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

Shanghai Jiao Tong University

Status: Completed

Conditions: End-stage Renal Disease

Treatments: Device: hemoperfusion combined with hemodialysis; Device: hemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03227770

XH-16-017

Details and patient eligibility

About

This multi-center, open-label, randomized controlled trial aims to investigate the efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and cardiovascular mortality in maintenance hemodialysis patients.

Full description

In this HD/HPvsHD trial, we plan to enroll 1364 maintenance hemodialysis patients. Eleven medical centers in Shanghai Metropolitan area have explicitly expressed interest to participate. Participants will be randomized to receive hemodialysis plus hemoperfusion or hemodialysis alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will receive lBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment at least 10 hours per week. In the experiment group, in addition to the treatments in the control arm, hemoperfusion will be conducted at least once every two weeks using a HA130 resin hemoperfusion apparatus containing 130ml resin. Follow-up is scheduled at 3, 6, 12, 18, 24 and up to 48 months after randomization, and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/kidney functions, tests of the coagulation system, etc.), chest X-ray, electrocardiogram, echocardiography, heart function rating (based on New York Heart Association grading). Dialysis adequacy defined by standard Kt/V will be calculated. Adverse events will be assessed according to the international conference on harmonization guidelines. The primary outcomes will include 24-month all-cause mortality. Secondary outcomes will include cardiovascular-related mortality, the occurrence of major cardiovascular events and the quality of life (Kidney Disease Quality of Life Short Form).

Enrollment: 1,362 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients must meet all of the following criteria are eligible:

1. Age ≥ 18 years old
2. Regular blood purification treatment at least 3 months before enrolled in this study

3. Standard Kt/V ≥ 1.2

Subjects with one of more of the following conditions will be excluded:

1. White blood cell count < 4×10^9/L and / or platelet count < 100×10^9/L
2. Cerebral hemorrhage in the past 12 weeks
3. MACEs in the past 8 weeks
4. Severe heart failure (New York Heart Association [NYHA] class IV)
5. Active gastrointestinal bleeding, or coagulation dysfunction
6. Malignant tumor
7. Active infection
8. Pregnancy or lactation 9) Mental disabilities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,362 participants in 2 patient groups

regular hemodialysis

Active Comparator group

Description:

Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week

Treatment:

Device: hemodialysis

hemoperfusion combined with hemodialysis

Experimental group

Description:

Combination of hemodialysis and hemoperfusion treatment at least once every two week

Treatment:

Device: hemoperfusion combined with hemodialysis

Device: hemodialysis