Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units (NCT06695611)
Evaluating the Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units (BP in HD Pilot Trial)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (10 items).
Location: University of Manitoba — Winnipeg, Manitoba
Age range: 18 Years
🧪 Interventions in This Study
- Increase systolic blood pressure (OTHER)
- Decrease systolic blood pressure (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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)
- Life expectancy \< 4 months
- Planned transition to home dialysis within 3 months
- Planned move to a different dialysis unit within 3 months
- Anticipated living donor kidney transplant within 3 months
- Other reasons as determined by treating clinician, reasons will be recorded
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Manitoba — Winnipeg, Manitoba
📞 Contact the Study Coordinator
Phone: (204) 632-3667
Email: rgirimonte@sogh.mb.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.