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

November 15, 2024 updated by: Navdeep Tangri, University of Manitoba

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite, blood pressure management being a cornerstone of multidisciplinary rounds, the optimal blood pressure target for people on hemodialysis is unknown. We plan to conduct a pilot study to determine if implementation of a pre-dialysis blood pressure protocol (as a unit-level policy) of a higher (150-170 mm Hg systolic) versus lower target (110-140 mm Hg systolic) in patients receiving chronic, in-centre hemodialysis is feasible?

This pilot study is a 4-centre pragmatic, two-arm, parallel-group, open-label cluster-randomized trial evaluating the feasibility of implementing a higher versus lower blood pressure target protocol. The intervention period will last 3 months, with check-ins at weeks 4 and 8 to see if clusters are able to meet their target blood pressures. If blood pressures are not at target at the week 4 check-in, a review between the study team and cluster will be conducted to determine how the target can be achieved.

Clusters will be randomized to a target pre-dialysis SBP of 110-140 mm Hg (the treatment arm) or 150-170 mm Hg (the standard arm). A 2-week average of standardized pre-dialysis systolic blood pressure readings measured in unknit will be used to define blood pressure targets and goals. Two weeks after a change to treatment has been made, SBP should be reassessed. If it is still above or below target range, another adjustment to course of treatment should be made. This interval allows for the effects of the change in treatment to be seen before any additional changes in treatment are made. The decision on how to adjust a participant's treatment in order to meet target blood pressure is up to the treating physician. This allows for more flexibility in treatment options and greater individuality in care. The treating physician can make treatment decisions based on individual needs, so as to better account for the participant's counter indication, comorbidities, and tolerances. Significant changes (both increases and decreases) in dry weight are not recommended. Changes in anti-hypertensive medication titration is the preferred option to adjust blood pressure before adjusting dry weight, sodium, and dialysis time.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2N2
        • University of Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Higher pre-dialysis blood pressure target (150-170 mm Hg systolic) (as a unit-level policy)
The approach to reach blood pressure target is up to the treating physician. Depending on baseline pre-dialysis systolic blood pressure, blood pressure may need to be raised or lowered to reach the target.
Other: 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
Other: 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
Experimental: Lower pre-dialysis blood pressure target (110-140 mm Hg systolic) (as a unit-level policy)
The approach to reach blood pressure target is up to the treating physician. Depending on baseline pre-dialysis systolic blood pressure, blood pressure may need to be raised or lowered to reach the target.
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in blood pressure between arms
Time Frame: Week 11 to13
Difference in 2-week average (week 11 to13) pre-dialysis SBP between treatment arms
Week 11 to13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Outcomes - Proportions
Time Frame: Week 13
  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
Week 13
Feasibility Outcomes - Change since baseline
Time Frame: Baseline and week 13
Change in dry weight
Baseline and week 13
Incidence of Adverse Events
Time Frame: Week 13
  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
Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Navdeep Tangri, MD, PhD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS26418 (B2024:040)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data comes from chart reviews and will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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