The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

A Randomized, Open-label, Multi-centre Trial Comparing Hemodialysis Plus Hemoperfusion Versus Hemodialysis Alone in Adult Patients With End-stage Renal Disease (HD/HPvsHD)

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

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.

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).

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

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)

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

Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment

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

Assessment of quality of life using the KDQOL-SF (Kidney Disease Quality of Life Short Form) questionnaire

Patients must meet all of the following criteria are eligible: Age ≥ 18 years old 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: White blood cell count < 4×10^9/L and / or platelet count < 100×10^9/L Cerebral hemorrhage in the past 12 weeks MACEs in the past 8 weeks Severe heart failure (New York Heart Association [NYHA] class IV) Active gastrointestinal bleeding, or coagulation dysfunction Malignant tumor Active infection Pregnancy or lactation 9) Mental disabilities

Lu W, Jiang GR; HD/HP versus HD trial Group. Randomised, open-label, multicentre trial comparing haemodialysis plus haemoperfusion versus haemodialysis alone in adult patients with end-stage renal disease (HD/HP vs HD): study protocol. BMJ Open. 2018 Jul 28;8(7):e022169. doi: 10.1136/bmjopen-2018-022169.