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.
Age > 18 years old
Undergoing in-centre hemodialysis at least twice weekly
> 90 days since initiation of dialysis
Participation in another intervention study that may affect blood pressure other than other cluster RCTs of dialysate composition
Inability to measure blood pressures in an upper arm
Pregnancy, anticipated pregnancy, or breastfeeding
Unmeasurable SBP (e.g., have left ventricular assist device)
Parallel
Increase systolic blood pressure
Other interventionTo 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
Other interventionTo 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
Difference in blood pressure between arms
Difference in 2-week average (week 11 to13) pre-dialysis SBP between treatment arms
Feasibility Outcomes - Proportions
1. The proportion of patients who reach target 2. The proportion of patients declined changing their prescribed SBP target 3. The proportion of patients for whom a care provider did not agree to changing the prescribed SBP target
Feasibility Outcomes - Change since baseline
Change in dry weight
Incidence of Adverse Events
1. Number of recorded cramps 2. Requirement for fluid bolus 3. SBP \<90 or \> 200 mm Hg requiring intervention 4. Hospitalizations or ER visits related to fluid overload 5. Dizziness, falls, or syncope 6. Vascular access thrombosis 7. Major adverse cardiovascular events
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