Hypertonic Mannitol for the Prevention of Intradialytic Hypotension: A Randomized Controlled Trial

Abstract

Intra-dialytic hypotension (IDH) is a common complication at the initiation of hemodialysis (HD) therapy, is associated with greater mortality, and may be related to relatively rapid shifts in plasma osmolality. This study sought to evaluate the effect of an intervention to minimize intra-dialytic changes in plasma osmolality on the occurrence of IDH. Double-blind single-center randomized controlled trial Individuals requiring initiation of HD for acute or chronic kidney disease Mannitol 0.25g/kg/h versus a similar volume of 0.9% saline during the first three HD sessions. The primary endpoint was the average decline in systolic blood pressure (SBP). The secondary endpoint was the proportion of total sessions complicated by IDH (defined as a drop of ≥20 mmHg from the pre-HD SBP). Exploratory endpoints included biomarkers of cardiac and kidney injury. A total of 52 patients were randomized and contributed to 156 study visits. There were no significant differences in the average SBP decline between the mannitol and placebo groups (15 ±11 vs. 19 ±16 mmHg; P=0.3). The proportion of total sessions complicated by IDH was lower in the mannitol group compared with placebo (25% vs. 43%), with a nominally lower risk of developing an episode of IDH (OR, 0.38; 95% CI, 0.14–1.00), though this finding was of borderline statistical significance (P=0.05). There were no consistent differences in cardiac and kidney injury biomarkers between treatment groups. Modest sample size and number of events In this pilot RCT studying patients requiring initiation of HD, we found no difference in the absolute SBP decline between those who received mannitol and those who received saline. However, there were fewer overall IDH events and a nominally lower risk of dialysis sessions being complicated by IDH in the mannitol group. A larger multi-center randomized controlled trial is warranted. Government funding to an author (Dr Mc Causland is supported by National Institute of Diabetes and Digestive and Kidney Diseases grant K23DK102511). Registered at ClinicalTrials.gov with study number .