Chronic Kidney Disease 5DNCT06695611
Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units
A study testing Increase systolic blood pressure and Decrease systolic blood pressure in people with Chronic Kidney Disease 5D, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease 5D
- What is being tested?
- Increase systolic blood pressure and Decrease systolic blood pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Undergoing in-centre hemodialysis at least twice weekly
- > 90 days since initiation of dialysis
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oksana Harasemiw, MSc contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease 5D
- Being tested
- Increase systolic blood pressure, Decrease systolic blood pressure
- Keywords
- Chronic Kidney Diseases, Blood Pressure, End Stage Renal Disease, Hemodialysis, Dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase systolic blood pressureOther
To increase systolic blood pressure, treating physicians can consider the following options:
- Withdraw blood pressure medications, reducing dose of medications that are not indicated for other reasons, or down titrate medication.
- Increase estimated dry weight (EDW) by 0.5 kg increments if the participant is hypovolemic or euvolemic
Decrease systolic blood pressureOther
To decrease SBP, treating physicians can consider the following options:
- 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.
- Reduce EDW by 0.1 - 0.5 kg
- 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
- Extend dialysis time or adding an additional dialysis session if needed to achieve target dry weight
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Increase systolic blood pressure; Other: Decrease systolic blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in blood pressure between arms
Difference in 2-week average (week 11 to13) pre-dialysis SBP between treatment arms
Measured: Week 11 to13
Secondary outcomes (3)
Feasibility Outcomes - Proportions
- The proportion of patients who reach target
- The proportion of patients declined changing their prescribed SBP target
- The proportion of patients for whom a care provider did not agree to changing the prescribed SBP target
Measured: Week 13
Feasibility Outcomes - Change since baseline
Change in dry weight
Measured: Baseline and week 13
Incidence of Adverse Events
- Number of recorded cramps
- Requirement for fluid bolus
- SBP <90 or > 200 mm Hg requiring intervention
- Hospitalizations or ER visits related to fluid overload
- Dizziness, falls, or syncope
- Vascular access thrombosis
- Major adverse cardiovascular events
Measured: Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study startFeb 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease 5DStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navdeep Tangri, University of Manitoba
- Investigators
- Navdeep Tangri, MD, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695611
- Sponsor's protocol ID
- HS26418 (B2024:040)
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data comes from chart reviews and will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units (BP in HD Pilot Trial)
- ClinicalTrials.gov ID
- NCT06695611
- Acronym / sponsor ID
- HS26418 (B2024:040)
- Conditions
- Chronic Kidney Disease 5D
- Keywords
- Chronic Kidney Diseases, Blood Pressure, End Stage Renal Disease, Hemodialysis, Dialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Higher pre-dialysis blood pressure target (150-170 mm Hg systolic) (as a unit-level policy) | Active comparator | Other: Increase systolic blood pressure, Other: Decrease systolic blood pressureThe 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. |
| Lower pre-dialysis blood pressure target (110-140 mm Hg systolic) (as a unit-level policy) | Experimental | Other: Increase systolic blood pressure, Other: Decrease systolic blood pressureThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old
- Undergoing in-centre hemodialysis at least twice weekly
- > 90 days since initiation of dialysis
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increase systolic blood pressureTo 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 | 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 pressureTo 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 | Other | 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) |
Primary outcome
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
3 secondary outcomes
Feasibility Outcomes - Proportions
Time frame: Week 13
Feasibility Outcomes - Change since baseline
Time frame: Baseline and week 13
Incidence of Adverse Events
Time frame: Week 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No. Individual participant data comes from chart reviews and will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oksana Harasemiw, MSc contact
Navdeep Tangri, MD, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase systolic blood pressure and Decrease systolic blood pressure in people with Chronic Kidney Disease 5D, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Girimonte, MSc (204-632-3667, rgirimonte@sogh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in blood pressure between arms (time frame: Week 11 to13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.