Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor A Randomized, Double-blind, Placebo-controlled, Cross Over Explorative Study
Vanderbilt University Medical Center
Summary
Currently, there is no medication available to adequately treat patients undergoing hemodialysis who are suffering from intradialytic hypotension (IDH). Medical interventions such as Trendelenburg positioning, saline bolus administration, reduction of ultrafiltration rate, interruption of the hemodialysis, and other medical treatments are the methods of choice to treat the hypotensive condition of these patients and thus to maintain the systolic blood pressure. Patients suffering from IDH have a higher reported mortality rate due to the given stress on their cardiovascular system. New treatments, therefore, would give clinicians an additional alternative to current existing approaches and might help patients to maintain their blood pressure during hemodialysis. The main objective of the study is to evaluate the efficacy of icatibant in the prevention of systolic blood pressure (SBP) drop in patients on hemodialysis suffering from recurrent IDH episodes during hemodialysis.
Description
Aim 1 is to test the hypothesis that in patients prone to IDH, blockade of bradykinin B2 receptor with icatibant prevents the drop of blood pressure and maintains hemodynamic stability. For this purpose, heart rate and blood pressure during hemodialysis are monitored. Importantly, the study will be conducted in an outpatient clinic, using the patients' usual hemodialysis dose and settings as for a regular hemodialysis session. Aim 2 is to test the hypothesis that in patients prone to IDH, inhibition of the plasma kallikrein system with icatibant prevents symptoms associated with IDH such as c…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients ≥ 18 to ≤ 80 years of age * Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for at least 6 months, receiving 3 dialysis sessions per week and who are in a stable clinical condition per investigator's judgement * Patients on hemodialysis with at least 6 IDH episodes during the last 8 weeks based on medical record assessment * Pre-dialysis systolic blood pressure ≥ 110 and ≤ 170 mmHg assessed by two consecutive and averaged pre-HD blood pressure measurments * Patients adequately hemodialyzed with a Kt/V ≥ 1.2 * Patients whose tr…
Interventions
- DrugIcatibant
Icatibant will be administered with an infusion rate of 100µg/kg/h for 15 minutes before their hemodialysis session (pre-infusion) and 50µg/kg/h during their routine hemodialysis session (maintenance infusion).
- DrugPlacebo
0.9% sodium chloride will be administered as the same rate as icatibant
Location
- Vanderbilt FreseniusNashville, Tennessee