End-stage Renal Disease
Conditions
Keywords
Hemoperfusion, Hemodialysis, Mortality
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).
Interventions
Hemoperfusion combined with hemodialysis treatment will perform at least once every two week. The hemoperfusion apparatus will use type HA130 resin hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)
DEVICEhemodialysis
Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week
Sponsors
Shanghai Zhongshan Hospital
RenJi Hospital
Ruijin Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai 6th People's Hospital
Changhai Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai University of Traditional Chinese Medicine
Shanghai Tongji Hospital, Tongji University School of Medicine
Yangpu District Central Hospital Affiliated to Tongji University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed