P1257SERTRALINE ADMINISTRATION TO PREVENT INTRADIALYTIC HYPOTENSION: A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, CROSSOVER STUDY (SLATAN STUDY)

Abstract

Abstract Background and Aims Intradialytic hypotension (IDH) is the most common intradialytic complication ranging from 15-50% in chronic hemodialysis patients and increases morbidity and mortality in this population. According to pathophysiology, various strategies have been applied to treat this condition. Autonomic dysfunction is the one of the factors leading to IDH and is commonly found in elderly and diabetes patients. The use of sertraline to improve autonomic function was done in some small studies but the benefits was inconclusive, especially in diabetic patients. This study aimed to clarify an efficacy of sertraline regarding IDH in hemodialysis patients. Method We conducted a single-center, randomized, double-blinded, placebo-controlled, crossover study on chronic hemodialysis patient who had IDH in at least 25% of their dialysis sessions. Each patient received either sertraline or placebo for 4 weeks and were crossed to the other group after washout period for 4 weeks. Sertraline was started at the dose of 50 mg/day during the first week and was increased to 100 mg/day from week 2 to week 4. Matching placebo was adjusted using the same protocol as sertraline. The primary outcome was an incidence of IDH. Secondary outcomes included an incidence of IDH in subgroup of the patients with and without diabetes, the changes of blood pressure during hemodialysis session, and incidence of adverse events. Intention-to-treat analysis was applied to all data analyses. Results A total of 37 patients were enrolled into the study (48.6% males, mean age of 64.0±15.5 years, mean dialysis vintage of 2.4±2.4 years). All patients in sertraline group completed the study; however, 4 patients in placebo group dropped out due to adverse effects. Baseline characteristics did not differ between both groups. By analysis of crossover design, an incidence of IDH in sertraline group was significantly lower than placebo group (2.5±2.3 episodes versus 4.2±2.7 episodes during study period of 4 weeks, p for treatment effect <0.001, p for period effect = 0.802, and p for sequence effect = 0.811). In subgroup of diabetes patients, an incidence of IDH in sertraline group was 2.5±2.2 episodes versus 4.4±2.8 episodes in placebo group (p for treatment effect = 0.001, p for period effect = 0.491, and p for sequence effect = 0.382). However, there was no difference in incidence of IDH between the two groups in non-diabetes patients. There was no significant difference of adverse events between the two groups. Conclusion Among patients undergoing chronic hemodialysis with intradialytic hypotension, administration of sertraline significantly decreases intradialytic hypotension episodes. In addition, diabetes patients may confer more benefit from the treatment compared with non-diabetes status.