Effects of combined haemodialysis-haemoadsorption therapy in maintenance haemodialysis patients: study protocol for a multicentre, open-label, randomised, parallel controlled trial.

INTRODUCTION: Haemodialysis (HD) is an essential treatment for end-stage renal disease patients to improve their quality of life. However, conventional HD may not effectively remove medium and large molecules and protein-bound toxins, leading to the occurrence of various complications. Haemoadsorption (HA), on the other hand, can address this limitation. Therefore, a multicentre, open-label, randomised, parallel controlled study will be conducted to compare HA combined with HD (HAHD) with HD alone in maintenance haemodialysis (MHD) patients. The primary endpoint is the change in serum β2-MG, PTH and CRP values. METHODS AND ANALYSIS: We plan to enrol 410 MHD patients from 10 participating medical centres in Shanghai. Patients will experience a 4-week washout period and a 52-week observation period. After the washout period, the eligible patients will be randomised in a 1:1 ratio to the two groups: the control group, 3 times/week conventional HD treatment; and the experiment group, 3 times/week conventional HD treatment+1 time/week HA treatment. The baseline and follow-up data at 0, 4, 12, 24, 36 and 52 weeks were collected from both groups, including the following: medical history, routine physical examination, dialysis regimen, laboratory tests, dialysis adequacy as defined by standard Kt/V, chest X-ray, ECG, cardiac ultrasound and three scales. Comorbidities, combined medications and adverse events will also be captured. The primary outcomes will include change in serum β2-MG, PTH and CRP values. Secondary outcomes will include change values for serum protein-bound toxins, improvement in patient quality of life, sleep disturbance and pruritus. ETHICS AND DISSEMINATION: The protocol has been approved by the Ethics Committees of 10 participating medical centres. Shanghai Changhai Hospital Ethics Committee will oversee the study. The results will be presented at national and international academic meetings, and publications will be submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05639010.