Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

Qualifiers

Age > 18 years old

Undergoing in-centre hemodialysis at least twice weekly

> 90 days since initiation of dialysis

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Increase systolic blood pressure
  • Decrease systolic blood pressure

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators