End Stage Renal DiseaseRADAR-ANCT03519347
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A
A study testing Potassium Removal Maximization, Potassium Gradient Minimization and Alkalosis Avoidance in people with End Stage Renal Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary purpose of this study is to test the feasibility of trials which change the dialysate (dialysis bath prescription) of potassium and bicarbonate according to a standardized algorithm and according to the results of blood testing performed prior to each dialysis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Potassium Removal Maximization, Potassium Gradient Minimization and Alkalosis Avoidance
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 14 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Maintenance hemodialysis therapy for end-stage renal disease
- Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
- >30 days since dialysis initiation
- Ability to provide informed consent
Who cannot join
- Expected survival <6 monthsRenal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
- Prisoners or cognitive disability preventing informed consent
- Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential >55 years old, women with a history of surgical sterilization, or for women <55 years of age who have not had a menses within the past 12 months.
- Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
- Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
- Existing pacemaker, implantable monitor or defibrillator which precludes device placement
- Chronic, persistent AF. Defined as the presence of persistent AF on all available EKGs at time of recent screening.
- Hemoglobin <8 g/dL-Serum K >6.5 or <3.5 mEq/L within 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Medicine
Durham, North Carolina, 27710
About this study
Official title: Radar-A: A Phase 2 Multi-center Study to Evaluate the Safety and Tolerability of Using Point-of-Care-Guided Manipulation of Dialysate Potassium and Dialysate Bicarbonate to Prevent Hemodialysis-Associated Arrhythmias
The primary purpose of this study is to test the feasibility of trials which change the dialysate (dialysis bath prescription) of potassium and bicarbonate according to a standardized algorithm and according to the results of blood testing performed prior to each dialysis. In addition, the trial will provide estimates of the extent to which performing dialysis in this way lowers the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.
Read the detailed description
Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR) (Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient Care Assistant which they will be required to keep for the duration of their participation in the study. ILR tracings will be uploaded automatically and reviewed by the study team for the occurrence of clinically significant arrhythmia.
Following ILR implantation, subjects will have 1 month of standard dialysis and will crossover in random order between four month-long periods of dialysis guided by the results of the point of care testing. Whole blood will be obtained by dialysis staff and immediately tested on a point of care chemistry analyzer according to the manufacturer's protocol prior to each dialysis session. The randomized intervention periods will include algorithms that alter the potassium bath in order to a) maximize potassium removal or b) minimize potassium removal as well as a second set of algorithms that alter the bicarbonate bath in order to c) limit acidosis or d) limit alkalosis.
- Conditions
- End Stage Renal Disease
- Being tested
- Potassium Removal Maximization, Potassium Gradient Minimization, Alkalosis Avoidance, Acidosis avoidance, Point of Care Testing
- Keywords
- arrythmia, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium Removal MaximizationOther
This intervention will test whether prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia reduces the incidence of clinically significant arrhythmias compared to an approach minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics.
Potassium Gradient MinimizationOther
This intervention will test whether minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients reduces the incidence of clinically significant arrhythmias compared to an approach prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics.
Alkalosis AvoidanceOther
The bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing alkalosis avoidance by use of lower dialysate HCO3 concentrations.
Acidosis avoidanceOther
The bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing acidosis avoidance by use of higher dialysate HCO3 concentrations.
Point of Care TestingDiagnostic test
Also called BLUE I-STAT CHEM8+
POC testing will use the Abbott BLUE I-STAT CHEM8+ , a portable, handheld device that provides lab quality analysis within 2-3 minutes using a few drops of whole blood (≤100uL).
Cardiac MonitorDevice
Also called LINQ (Medtronic) Implantable Cardiac Loop Recorder (Carelink System)
Device is one-third of the size of a triple-A battery and is placed subcutaneously in the left chest during a brief procedure that can be done in-office under local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Potassium Removal Maximization Strategy | Experimental | Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia. Receives: Other: Potassium Removal Maximization; Diagnostic Test: Point of Care Testing; Device: Cardiac Monitor |
| Potassium Gradient Minimization Strategy | Experimental | Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium. Receives: Other: Potassium Gradient Minimization; Diagnostic Test: Point of Care Testing; Device: Cardiac Monitor |
| Alkalosis Avoidance Strategy | Experimental | Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis. Receives: Other: Alkalosis Avoidance; Diagnostic Test: Point of Care Testing; Device: Cardiac Monitor |
| Acidosis Avoidance Strategy | Experimental | Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis. Receives: Other: Acidosis avoidance; Diagnostic Test: Point of Care Testing; Device: Cardiac Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence With Proposed Interventions
Adherence will be assessed as the percent of sessions in which POC testing is completed and the dialysate is adjusted according to the algorithm.
Measured: Up to Week 24
Number of Participants Enrolled Per Month
Assessment of recruitment feasibility.
Measured: Up to Week 24
Proportion of Participants Who Experienced Potassium Intervention-Specific Complications
Potassium Intervention-Specific Complications are defined as either severe potassium abnormalities (potassium ≥ 6.5 or ≤ 3.0 mEq/L) or unscheduled HD or hospitalization for hyper/hypokalemia in the absence of a missed treatment.
Measured: Up to Week 24
Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications
Bicarbonate Intervention-Specific Complications are defined as severe HCO3 abnormalities (HCO3 <20 or >32 mEq/L) or unscheduled HD or hospitalization for acid base abnormalities in the absence of a missed treatment.
Measured: Up to Week 24
Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)
CSA will be defined on the basis of arrhythmias likely to lead to sudden cardiac arrest (SCA) or serious morbidity and mortality and will include AF, asystole ≥3 seconds, bradycardia ≤40 beats per minute lasting ≥6 seconds, and sustained VT ≥130 beats per minute lasting ≥30 seconds.
Measured: Up to Week 24
Secondary outcomes (7)
Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription
The impact of POC testing on trial design will be measured as the percent of sessions in which the POC-guided dialysate prescription differs from a hypothetical prescription in which the choice of dialysate is based solely on the once-monthly lab (usual care).
Measured: Up to Week 24
Mean Duration of Atrial Fibrillation
Measured: Up to Week 24
Incidence of Potentially Lethal Arrhythmias
Potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds.
Measured: Up to Week 24
Number of Screened Patients Who Are Enrolled
Secondary feasibility measure to assess the size of the necessary screening pool.
Measured: Up to Week 24
Incidence of Hospitalization
Measured: Up to Week 24
All-Cause Mortality
Number of participants who die due to any cause.
Measured: Up to Week 24
Cardiovascular Mortality
Number of participants who die due to cardiovascular-related causes.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start30 Nov 2018
- Primary completion12 Jul 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Duke University, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- David Charytan, MD, MSc, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519347
- Sponsor's protocol ID
- 18-01324
- Other IDs
- R34HL140477-01
- Acronym
- RADAR-A
- Status last verified
- Jul 2023
- First submitted
- 26 Apr 2018
- Last updated
- 15 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radar-A: A Phase 2 Multi-center Study to Evaluate the Safety and Tolerability of Using Point-of-Care-Guided Manipulation of Dialysate Potassium and Dialysate Bicarbonate to Prevent Hemodialysis-Associated Arrhythmias
- ClinicalTrials.gov ID
- NCT03519347
- Acronym / sponsor ID
- RADAR-A / 18-01324
- Conditions
- End Stage Renal Disease
- Keywords
- arrythmia, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Duke University, National Institutes of Health (NIH)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 15 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to test the feasibility of trials which change the dialysate (dialysis bath prescription) of potassium and bicarbonate according to a standardized algorithm and according to the results of blood testing performed prior to each dialysis. In addition, the trial will provide estimates of the extent to which performing dialysis in this way lowers the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.
Detailed description
Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR) (Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient Care Assistant which they will be required to keep for the duration of their participation in the study. ILR tracings will be uploaded automatically and reviewed by the study team for the occurrence of clinically significant arrhythmia.
Following ILR implantation, subjects will have 1 month of standard dialysis and will crossover in random order between four month-long periods of dialysis guided by the results of the point of care testing. Whole blood will be obtained by dialysis staff and immediately tested on a point of care chemistry analyzer according to the manufacturer's protocol prior to each dialysis session. The randomized intervention periods will include algorithms that alter the potassium bath in order to a) maximize potassium removal or b) minimize potassium removal as well as a second set of algorithms that alter the bicarbonate bath in order to c) limit acidosis or d) limit alkalosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Potassium Removal Maximization Strategy | Experimental | Other: Potassium Removal Maximization, Diagnostic Test: Point of Care Testing, Device: Cardiac MonitorDialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia. |
| Potassium Gradient Minimization Strategy | Experimental | Other: Potassium Gradient Minimization, Diagnostic Test: Point of Care Testing, Device: Cardiac MonitorDialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium. |
| Alkalosis Avoidance Strategy | Experimental | Other: Alkalosis Avoidance, Diagnostic Test: Point of Care Testing, Device: Cardiac MonitorDialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis. |
| Acidosis Avoidance Strategy | Experimental | Other: Acidosis avoidance, Diagnostic Test: Point of Care Testing, Device: Cardiac MonitorDialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Maintenance hemodialysis therapy for end-stage renal disease
- Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
- >30 days since dialysis initiation
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- Expected survival <6 monthsRenal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
- Prisoners or cognitive disability preventing informed consent
- Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential >55 years old, women with a history of surgical sterilization, or for women <55 years of age who have not had a menses within the past 12 months.
- Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
- Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
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 |
|---|---|---|
| Potassium Removal MaximizationThis intervention will test whether prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia reduces the incidence of clinically significant arrhythmias compared to an approach minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics. | Other | Potassium Removal Maximization Strategy |
| Potassium Gradient MinimizationThis intervention will test whether minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients reduces the incidence of clinically significant arrhythmias compared to an approach prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics. | Other | Potassium Gradient Minimization Strategy |
| Alkalosis AvoidanceThe bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing alkalosis avoidance by use of lower dialysate HCO3 concentrations. | Other | Alkalosis Avoidance Strategy |
| Acidosis avoidanceThe bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing acidosis avoidance by use of higher dialysate HCO3 concentrations. | Other | Acidosis Avoidance Strategy |
| Point of Care TestingAlso: BLUE I-STAT CHEM8+POC testing will use the Abbott BLUE I-STAT CHEM8+ , a portable, handheld device that provides lab quality analysis within 2-3 minutes using a few drops of whole blood (≤100uL). | Diagnostic test | Acidosis Avoidance Strategy, Alkalosis Avoidance Strategy, Potassium Gradient Minimization Strategy, Potassium Removal Maximization Strategy |
| Cardiac MonitorAlso: LINQ (Medtronic) Implantable Cardiac Loop Recorder (Carelink System)Device is one-third of the size of a triple-A battery and is placed subcutaneously in the left chest during a brief procedure that can be done in-office under local anesthesia. | Device | Acidosis Avoidance Strategy, Alkalosis Avoidance Strategy, Potassium Gradient Minimization Strategy, Potassium Removal Maximization Strategy |
Primary outcome
Adherence With Proposed Interventions
Time frame: Up to Week 24
Adherence will be assessed as the percent of sessions in which POC testing is completed and the dialysate is adjusted according to the algorithm.
Number of Participants Enrolled Per Month
Time frame: Up to Week 24
Assessment of recruitment feasibility.
Proportion of Participants Who Experienced Potassium Intervention-Specific Complications
Time frame: Up to Week 24
Potassium Intervention-Specific Complications are defined as either severe potassium abnormalities (potassium ≥ 6.5 or ≤ 3.0 mEq/L) or unscheduled HD or hospitalization for hyper/hypokalemia in the absence of a missed treatment.
Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications
Time frame: Up to Week 24
Bicarbonate Intervention-Specific Complications are defined as severe HCO3 abnormalities (HCO3 <20 or >32 mEq/L) or unscheduled HD or hospitalization for acid base abnormalities in the absence of a missed treatment.
Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)
Time frame: Up to Week 24
CSA will be defined on the basis of arrhythmias likely to lead to sudden cardiac arrest (SCA) or serious morbidity and mortality and will include AF, asystole ≥3 seconds, bradycardia ≤40 beats per minute lasting ≥6 seconds, and sustained VT ≥130 beats per minute lasting ≥30 seconds.
7 secondary outcomes
Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription
Time frame: Up to Week 24
Mean Duration of Atrial Fibrillation
Time frame: Up to Week 24
Incidence of Potentially Lethal Arrhythmias
Time frame: Up to Week 24
Number of Screened Patients Who Are Enrolled
Time frame: Up to Week 24
Incidence of Hospitalization
Time frame: Up to Week 24
All-Cause Mortality
Time frame: Up to Week 24
Cardiovascular Mortality
Time frame: Up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
David Charytan, MD, MSc principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium Removal Maximization, Potassium Gradient Minimization and Alkalosis Avoidance in people with End Stage Renal Disease, run by NYU Langone Health at 1 site in United States.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 15 Aug 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence With Proposed Interventions (time frame: Up to Week 24). The study lists 5 primary outcomes in all. 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 15 Aug 2023.