Glucose-containing vs. glucose-free dialysate for patients with maintenance hemodialysis: Study protocol for a multicenter randomized controlled study-GLUMO study.

PURPOSE: To mitigate the risk of infection and disordered blood lipid metabolism, glucose-free dialysate is widely utilized in China and European countries. While glucose-free dialysis does not necessarily lead to hypoglycemia, several other metabolic adjustments must occur to maintain normal blood glucose levels. Additionally, glucose-free dialysis may also increase the loss of amino acids and the susceptibility to hypotension and cardiovascular events. Incorporating an appropriate amount of glucose into the dialysate can help to offset the insufficient blood glucose during hemodialysis (HD), potentially reducing the incidence of hypoglycemia. Currently, the efficacy and safety of glucose-containing dialysate during HD remain contentious, and this study will be conducted to evaluate the efficacy and safety of 5.5 mmol/L glucose-containing dialysate for maintenance HD patients.

STUDY DESIGN AND METHODS: A multicenter, prospective, open-label, parallel-group, randomized controlled trial (RCT) will be conducted at more than 30 dialysis centers in China. Approximately 600 participants undergoing maintenance HD will be enrolled. Eligible patients will be randomly assigned to two groups, receiving either glucose-containing dialysate or glucose-free dialysate for HD at a 1:1 ratio, determined by a central computer-generated randomized sequence. The primary outcome is the incidence of the major cardiovascular and cerebrovascular adverse events (MACCE). Secondary outcomes are all-cause mortality, incidence of intradialytic hypotension (IDH), incidence of hypoglycemia, blood pressure and blood glucose variability, dysfunction of vascular access, cardiac function and fatigue level. Outcome assessors and data analysts will be blinded. All data will be analyzed using either intention-to-treat or per-protocol analysis methods.

DISCUSSION: The results of this study will provide evidence on the efficacy and safety of 5.5 mmol/L glucose-containing dialysate for maintenance HD patients, and will provide valuable insights for future dialysate selection and the enhancement of dialysis treatment prescriptions.

TRIAL REGISTRATION NUMBER: ChiCTR2400083153.