Sertraline Administration to Prevent Intradialytic Hypotension: A Randomized, Double-Blind, Placebo-Controlled Crossover Study (SLATAN Study)

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Introduction: Intradialytic hypotension (IDH) is common during hemodialysis and is associated with adverse outcomes. Although sertraline may improve autonomic dysfunction, which contributes to the pathogenesis of IDH, its efficacy in preventing IDH remains uncertain. Methods: We conducted a prospective, randomized, double-blind, placebo-controlled, crossover trial in maintenance hemodialysis patients with IDH in ≥25% of sessions. Participants received sertraline or placebo for 4 weeks, followed by a 4-week washout before crossover (total 12 weeks). Sertraline was initiated at 50 mg/day for 1 week and increased to 100 mg/day for weeks 2-4. Primary outcome was the incidence of IDH. Secondary outcomes included IDH incidence stratified by diabetes status, symptomatic IDH, therapeutic interventions, intradialytic blood pressure changes, and adverse events. Results: Thirty-seven patients were enrolled (mean age 64.0 years; 49% male; median dialysis vintage 24 months). In the intention-to-treat analysis, sertraline significantly reduced IDH episodes compared with placebo (2.5 vs 4.2 episodes per patient, p for treatment effect<0.001, period effect=0.607, sequence effect=0.577). Among diabetic patients, IDH incidence was lower with sertraline (2.5 vs 4.3 episodes per patient, p<0.001), whereas no difference was observed in non-diabetic patients. Sertraline also reduced symptomatic IDH (0.5% vs. 1.4%, p=0.036) and therapeutic interventions (5.2 vs. 8.4 events, p=0.001). Systolic blood pressure and mean arterial pressure at 1- and 3-hours during dialysis were significantly higher with sertraline. Adverse events were comparable. Conclusions: In maintenance hemodialysis patients with frequent IDH, sertraline significantly reduced IDH episodes, particularly among those with diabetes, decreased symptomatic events and rescue interventions, and improved intradialytic hemodynamic stability.