A randomized controlled trial of two dialysate sodium concentrations in hospitalized hemodialysis patients

Abstract

Background Several large dialysis organizations have lowered the dialysate sodium concentration (DNa) in an effort to ameliorate hypervolemia. The implications of lower DNa on intra-dialytic hypotension (IDH) during hospitalizations of hemodialysis (HD) patients is unclear. Methods In this double-blind single center randomized controlled trial, hospitalized maintenance HD patients were randomized to receive higher (142 mmol/L) or lower (138 mmol/L) DNa for up to six sessions. Blood pressure (BP) was measured in a standardized fashion pre-HD, post-HD and every 15 minutes during HD. The endpoints were: 1) the average decline in systolic BP (pre-HD minus lowest intra-HD; primary endpoint); and 2) the proportion of total sessions complicated by IDH (drop of ≥20 mmHg from the pre-HD systolic BP; secondary endpoint). Results A total of 139 patients completed the trial, contributing 311 study visits. There were no significant differences in the average SBP decline between the higher and lower DNa groups (23 ±16 vs. 26 ±16 mmHg; P = 0.57). The proportion of total sessions complicated by IDH was similar in the higher DNa group, compared with the lower DNa group (54% vs. 59%; OR 0.72; 95%CI 0.36 to 1.44; P = 0.35). In post-hoc analyses adjusting for imbalances in baseline characteristics, higher DNa was associated with 8 mmHg (95%CI 2 to 13 mmHg) less decline in SBP, compared with lower DNa. Patient symptoms and adverse events were similar between groups. Conclusions In this RCT for hospitalized maintenance HD patients, we found no difference in the absolute SBP decline between those who received higher versus lower DNa in intention-to-treat analyses. Post-hoc adjusted analyses suggested a lower risk of IDH with higher DNa – thus, larger multi-center studies to confirm these findings are warranted.

Personalized prevention and treatment strategies for hypotension patients during maintenance hemodialysis

“…The different effects of heterogeneity of dialysis prescriptions on patients' clinical outcomes have been confirmed by many studies. Personalized dialysate with high sodium concentration [4] , high magnesium concentration, high calcium concentration and low temperature [5] all have potential benefits in reducing the risk of IDH. For patients at high risk of IDH, it is recommended to limit the ultrafiltration rate to 12ml/kg/h or to use hemodiafiltration [6,7] .…”

Application Value of Limb Ischemic Preconditioning in Preventing Intradialytic Hypotension during Maintenance Hemodialysis

“…Due to the use of different IDH standards, the incidence of IDH varies greatly from 10% to 70% in different articles [ 1 ]. Although there are many strategies in the treatment and prevention of IDH at home and abroad such as the use of cooled dialysate [ 2 ], the monitoring of relative blood volume [ 3 ], the biofeedback control of ultrafiltration rate, low-temperature sodium-adjustable dialysis [ 4 ] and drug intervention [ 5 ], the incidence of IDH is still high after all these strategies are implemented and popularized in clinical practice. Therefore, IDH is still a common and serious problem in hemodialysis.…”

Are Observational Reports on the Association of Dialysate Sodium with Mortality Enough to Change Practice? Perspective from the RESOLVE Study Team

“…A relatively small randomized evidence base suggests improvements in some short-term cardiovascular surrogates. The randomized evidence base of ,700 patients in 15 trials [6][7][8][9] shows beneficial effects overall for some surrogates, including lower SBP and less interdialytic weight gain. An improvement in BP is persuasive, given the benefits for pharmaceutically induced blood pressure lowering in the dialysis 10 as well as the general population.…”