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

NCT06695611 | Not Yet Recruiting DMC

• 1 other identifier: HS26418 (B2024:040)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease 5D

Keywords

Chronic Kidney Diseases; Blood Pressure; End Stage Renal Disease; Hemodialysis; Dialysis

Outcome Measures

Primary Outcomes (1)

• Difference in blood pressure between arms

  Difference in 2-week average (week 11 to13) pre-dialysis SBP between treatment arms

  Week 11 to13

Secondary Outcomes (3)

• Feasibility Outcomes - Proportions

  Week 13

• Feasibility Outcomes - Change since baseline

  Baseline and week 13

• Incidence of Adverse Events

  Week 13

Study Arms (2)

Higher pre-dialysis blood pressure target (150-170 mm Hg systolic) (as a unit-level policy)

ACTIVE COMPARATOR

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; Other: Decrease systolic blood pressure

Lower pre-dialysis blood pressure target (110-140 mm Hg systolic) (as a unit-level policy)

EXPERIMENTAL

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; Other: Decrease systolic blood pressure

Interventions

Increase systolic blood pressure OTHER

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

Higher pre-dialysis blood pressure target (150-170 mm Hg systolic) (as a unit-level policy); Lower pre-dialysis blood pressure target (110-140 mm Hg systolic) (as a unit-level policy)

Decrease systolic blood pressure OTHER

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

Higher pre-dialysis blood pressure target (150-170 mm Hg systolic) (as a unit-level policy); Lower pre-dialysis blood pressure target (110-140 mm Hg systolic) (as a unit-level policy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Navdeep Tangri, MD, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Girimonte, MSc

CONTACT

204-632-3667; rgirimonte@sogh.mb.ca

Oksana Harasemiw, MSc

CONTACT

oharasemiw@sogh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As this is an open-label cluster randomization, the unit staff and patients will be aware of their unit's target blood pressure. The statistician performing the data analysis will be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/Professor

Model Details: 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

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 19, 2024
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)