Study of Icatibant to Prevent Blood Pressure Drops During Hemodialysis in Adults with Intradialytic Hypotension

What this Trial Is About

Researchers are evaluating the use of icatibant, a drug that blocks the bradykinin B2 receptor, to prevent drops in systolic blood pressure in patients undergoing hemodialysis who frequently experience intradialytic hypotension IDH. IDH causes a dangerous decline in blood pressure during dialysis, leading to symptoms like cramps, dizziness, and nausea, and is associated with higher mortality due to cardiovascular stress. The study aims to explore whether icatibant can maintain blood pressure and improve quality of life and recovery time after dialysis. Participants will receive either icatibant or a placebo during their hemodialysis sessions in a randomized, double-blind, crossover design. Icatibant is given by intravenous infusion with a pre-infusion dose before dialysis and a maintenance infusion during dialysis, while the placebo group receives a saline infusion at the same rate. Each treatment lasts four weeks, covering 12 dialysis sessions, and is conducted in an outpatient setting using patients usual dialysis settings. During the study, heart rate and blood pressure will be closely monitored throughout hemodialysis sessions. Researchers will track episodes of hypotension, symptoms related to low blood pressure, and overall quality of life and recovery after dialysis. The studys primary measure is blood pressure stability during dialysis over an 8-week period. Participants safety and treatment effects will be observed through regular assessments, with the total study duration covering the treatment and monitoring phases.

Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor