Trial Outcomes & Findings for Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A (NCT NCT03519347)
NCT ID: NCT03519347
Last Updated: 2023-08-15
Results Overview
Adherence will be assessed as the percent of sessions in which POC testing is completed and the dialysate is adjusted according to the algorithm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Up to Week 24
Results posted on
2023-08-15
Participant Flow
Participant milestones
| Measure |
Intervention Sequence B1B2K1K2
Participants assigned to receive Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy, then Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy.
|
Intervention Sequence B2B1K2K1
Participants assigned to receive Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy, then Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy.
|
Intervention Sequence K1K2B1B2
Participants assigned to receive Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy, then Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy.
|
Intervention Sequence K2K1B2B1
Participants assigned to receive Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy, then Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy.
|
|---|---|---|---|---|
|
Baseline Observation Period
STARTED
|
5
|
4
|
4
|
6
|
|
Baseline Observation Period
COMPLETED
|
5
|
4
|
4
|
6
|
|
Baseline Observation Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Interventional Crossover Period 1
STARTED
|
5
|
4
|
4
|
6
|
|
Interventional Crossover Period 1
COMPLETED
|
5
|
4
|
4
|
5
|
|
Interventional Crossover Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Interventional Crossover Period 2
STARTED
|
4
|
4
|
4
|
5
|
|
Interventional Crossover Period 2
COMPLETED
|
4
|
4
|
4
|
5
|
|
Interventional Crossover Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Interventional Crossover Period 3
STARTED
|
3
|
4
|
4
|
5
|
|
Interventional Crossover Period 3
COMPLETED
|
3
|
4
|
4
|
5
|
|
Interventional Crossover Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Interventional Crossover Period 4
STARTED
|
3
|
4
|
3
|
5
|
|
Interventional Crossover Period 4
COMPLETED
|
3
|
4
|
3
|
5
|
|
Interventional Crossover Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Intervention Sequence B1B2K1K2
Participants assigned to receive Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy, then Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy.
|
Intervention Sequence B2B1K2K1
Participants assigned to receive Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy, then Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy.
|
Intervention Sequence K1K2B1B2
Participants assigned to receive Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy, then Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy.
|
Intervention Sequence K2K1B2B1
Participants assigned to receive Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy, then Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy.
|
|---|---|---|---|---|
|
Interventional Crossover Period 1
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A
Baseline characteristics by cohort
| Measure |
Intervention Sequence B1B2K1K2
n=5 Participants
Participants assigned to receive Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy, then Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy.
|
Intervention Sequence B2B1K2K1
n=4 Participants
Participants assigned to receive Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy, then Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy.
|
Intervention Sequence K1K2B1B2
n=4 Participants
Participants assigned to receive Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy, then Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy.
|
Intervention Sequence K2K1B2B1
n=6 Participants
Participants assigned to receive Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy, then Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 8.92 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
59.9 years
STANDARD_DEVIATION 11.655 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
19 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Adherence will be assessed as the percent of sessions in which POC testing is completed and the dialysate is adjusted according to the algorithm.
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Adherence With Proposed Interventions
|
88 Percentage of sessions
Interval 82.0 to 92.0
|
90 Percentage of sessions
Interval 85.0 to 94.0
|
83 Percentage of sessions
Interval 77.0 to 88.0
|
80 Percentage of sessions
Interval 74.0 to 85.0
|
PRIMARY outcome
Timeframe: Up to Week 24Assessment of recruitment feasibility.
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=19 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Number of Participants Enrolled Per Month
|
0.7 Patients per month
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 24Potassium 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.
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Proportion of Participants Who Experienced Potassium Intervention-Specific Complications
|
0.0062 Proportion of participants
|
0 Proportion of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 24Bicarbonate 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.
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications
|
0.17 Proportion of participants
Interval 0.11 to 0.25
|
0.046 Proportion of participants
Interval 0.02 to 0.09
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 24CSA 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.
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)
|
497 Seconds
Standard Deviation 817
|
60.8 Seconds
Standard Deviation 56
|
1020 Seconds
Standard Deviation 2060
|
7950 Seconds
Standard Deviation 26000
|
SECONDARY outcome
Timeframe: Up to Week 24The 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).
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription
|
55.80 Percentage of sessions
Standard Deviation 49.10
|
41.20 Percentage of sessions
Standard Deviation 33.70
|
90.20 Percentage of sessions
Standard Deviation 20.10
|
88.90 Percentage of sessions
Standard Deviation 26.20
|
SECONDARY outcome
Timeframe: Up to Week 24Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Mean Duration of Atrial Fibrillation
|
1440 Seconds
Standard Deviation 0
|
120 Seconds
Standard Deviation 0
|
1170 Seconds
Standard Deviation 2180
|
189 Seconds
Standard Deviation 110
|
SECONDARY outcome
Timeframe: Up to Week 24Potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds.
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Incidence of Potentially Lethal Arrhythmias
|
2 Number of Potentially Lethal Arrhythmias
Standard Deviation 1.32
|
2 Number of Potentially Lethal Arrhythmias
Standard Deviation 1.32
|
0 Number of Potentially Lethal Arrhythmias
Standard Deviation 0
|
3 Number of Potentially Lethal Arrhythmias
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Up to Week 24Secondary feasibility measure to assess the size of the necessary screening pool.
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=94 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Number of Screened Patients Who Are Enrolled
|
19 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Incidence of Hospitalization
|
3 Number of Hospitalizations
|
4 Number of Hospitalizations
|
2 Number of Hospitalizations
|
3 Number of Hospitalizations
|
SECONDARY outcome
Timeframe: Up to Week 24Number of participants who die due to any cause.
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
All-Cause Mortality
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Number of participants who die due to cardiovascular-related causes.
Outcome measures
| Measure |
Potassium Removal Maximization Strategy
n=17 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 Participants
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 Participants
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Cardiovascular Mortality
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Potassium Removal Maximization Strategy
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Potassium Gradient Minimization Strategy
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Alkalosis Avoidance Strategy
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
Acidosis Avoidance Strategy
Serious events: 5 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Potassium Removal Maximization Strategy
n=17 participants at risk
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 participants at risk
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 participants at risk
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 participants at risk
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Peripheral Angiogram
|
0.00%
0/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
5.9%
1/17 • 6 months
regular investigator assessment
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
12.5%
2/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/17 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Infections and infestations
COVID-19
|
0.00%
0/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
5.9%
1/17 • 6 months
regular investigator assessment
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
5.9%
1/17 • 6 months
regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/17 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
5.9%
1/17 • 6 months
regular investigator assessment
|
|
Surgical and medical procedures
Illeostomy closure
|
0.00%
0/17 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
5.9%
1/17 • 6 months
regular investigator assessment
|
|
Eye disorders
Sudden visual loss
|
0.00%
0/17 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Vascular disorders
Vascular access site complication
|
11.8%
2/17 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
5.9%
1/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
Other adverse events
| Measure |
Potassium Removal Maximization Strategy
n=17 participants at risk
Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Potassium Gradient Minimization Strategy
n=16 participants at risk
Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization: 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.
Point of Care Testing: 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 Monitor: 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.
|
Alkalosis Avoidance Strategy
n=16 participants at risk
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Alkalosis Avoidance: 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.
Point of Care Testing: 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 Monitor: 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.
|
Acidosis Avoidance Strategy
n=17 participants at risk
Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis avoidance: 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 Testing: 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 Monitor: 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.
|
|---|---|---|---|---|
|
Infections and infestations
Abcess
|
0.00%
0/17 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
0.00%
0/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Vascular disorders
Cramping
|
0.00%
0/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
5.9%
1/17 • 6 months
regular investigator assessment
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.9%
1/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
1/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Renal and urinary disorders
Kidney stones
|
5.9%
1/17 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
5.9%
1/17 • 6 months
regular investigator assessment
|
|
Cardiac disorders
Palpitations
|
0.00%
0/17 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Injury, poisoning and procedural complications
Puncture wound
|
0.00%
0/17 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
0.00%
0/17 • 6 months
regular investigator assessment
|
|
Vascular disorders
Vascular access site complication
|
5.9%
1/17 • 6 months
regular investigator assessment
|
0.00%
0/16 • 6 months
regular investigator assessment
|
6.2%
1/16 • 6 months
regular investigator assessment
|
5.9%
1/17 • 6 months
regular investigator assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place