The Benefit of Hemodialysis Plus Hemoperfusion on Mortality
- Conditions
- End-stage Renal Disease
- Interventions
- Device: hemodialysisDevice: hemoperfusion combined with hemodialysis
- Registration Number
- NCT03227770
- Brief Summary
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.
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1362
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description regular hemodialysis hemodialysis Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week hemoperfusion combined with hemodialysis hemoperfusion combined with hemodialysis Combination of hemodialysis and hemoperfusion treatment at least once every two week hemoperfusion combined with hemodialysis hemodialysis Combination of hemodialysis and hemoperfusion treatment at least once every two week
- Primary Outcome Measures
Name Time Method All-cause mortality From date of enrollment until the end of study, assessed up to 24 months Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment
- Secondary Outcome Measures
Name Time Method Cardiovascular-related mortality and major cardiovascular events (MACEs) From date of enrollment until the end of study, assessed up to 24 months Major cardiovascular events events including angina pectoris, acute myocardial infarction, severe arrhythmia, congestive heart failure, myocarditis, pericarditis, cardiac surgery or peripheral vascular surgery, stroke and peripheral vascular disease
Evaluation of quality of life From date of enrollment until the end of study, assessed up to 24 months Assessment of quality of life using the KDQOL-SF (Kidney Disease Quality of Life Short Form) questionnaire
Trial Locations
- Locations (11)
Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai 6th People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
RenJi Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Shanghai Tongji Hospital, Tongji University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Yangpu District Central Hospital Affiliated to Tongji University
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China