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NCT06695611Not yet recruiting

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

Evaluating the Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units (BP in HD Pilot Trial)

Source: ClinicalTrials.gov · Last updated 19 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
28 Oct 2024
Start date
Feb 2025
Primary completion date
Dec 2025
Lead sponsor
University of Manitoba
NCT number
NCT06695611

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From Feb 2025 to the primary completion date, Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Anticipated living donor kidney transplant within 3 months

Other

  • 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
  • Other reasons as determined by treating clinician, reasons will be recorded

Who the study is looking for

  • Age \> 18 years old
  • Undergoing in-centre hemodialysis at least twice weekly
  • \> 90 days since initiation of dialysis

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Manitoba
Coordinator of this site? Confirm its status
WinnipegCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.