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Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units
Sponsor: University of Manitoba
Summary
High blood pressure in people receiving hemodialysis is known to contribute to heart disease and heart-related death from strokes, heart failure, left ventricular hypertrophy (which is a thickening of the heart wall that makes it difficult for the heart to pump blood) and arrythmias (an irregular or abnormal heartbeat). In comparison, low blood pressure can lead to cramps, myocardial stunning, and cerebrovascular ischemia. However, despite, blood pressure management being an important component of hemodialysis care, the "best" blood pressure target for people on hemodialysis is unknown. Finding the "right" blood pressure to target can have a major impact on patient lives. We are proposing a large, pragmatic, cluster randomized trial targeting a lower versus higher blood pressure target in in-centre hemodialysis units in Canada. Our initial steps towards this bigger trial are to run a smaller trial including 4 units, to evaluate whether it is feasible to conduct a larger trial. Our ultimate goal is to deliver the definitive randomized trial for blood pressure targets in the hemodialysis population.
Official title: Evaluating the Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units (BP in HD Pilot Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-02
Completion Date
2025-12
Last Updated
2024-11-19
Healthy Volunteers
No
Conditions
Interventions
Increase systolic blood pressure
To increase systolic blood pressure, treating physicians can consider the following options: 1. Withdraw blood pressure medications, reducing dose of medications that are not indicated for other reasons, or down titrate medication. 2. Increase estimated dry weight (EDW) by 0.5 kg increments if the participant is hypovolemic or euvolemic
Decrease systolic blood pressure
To decrease SBP, treating physicians can consider the following options: 1. Adjust blood pressure medications. This could be accomplished by increasing the dose of current medications, and/or adding an additional medication class. Choice of medication will be dependent on current medications, contraindications, age, comorbidities, and cardiovascular indications. Adherence to blood pressure medications should be reviewed. 2. Reduce EDW by 0.1 - 0.5 kg 3. Reduce sodium levels. This could be accomplished through a reduction in dietary sodium intake to \<2 gm/day and fluid intake to \<1.5 L per day. Adherence to dietary sodium restrictions should be reviewed with the participant 4. Extend dialysis time or adding an additional dialysis session if needed to achieve target dry weight
Locations (1)
University of Manitoba
Winnipeg, Manitoba, Canada