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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL140477-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Duke University | OTHER |
| National Institutes of Health (NIH) | NIH |
Not provided
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Removal Maximization | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 24 |
| Number of Participants Enrolled Per Month | Assessment of recruitment feasibility. | 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. | 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. | 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. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| David Charytan, MD, MSc | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University School of Medicine | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Sequence B1B2K1K2 | Participants assigned to receive Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy, then Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy. |
| FG001 | Intervention Sequence B2B1K2K1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Observation Period |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Potassium Gradient Minimization | Other | 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 Avoidance | Other | 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 avoidance | Other | 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 | Diagnostic Test | 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 | 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 | Up to Week 24 |
| Incidence of Potentially Lethal Arrhythmias | Potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds. | Up to Week 24 |
| Number of Screened Patients Who Are Enrolled | Secondary feasibility measure to assess the size of the necessary screening pool. | Up to Week 24 |
| Incidence of Hospitalization | Up to Week 24 |
| All-Cause Mortality | Number of participants who die due to any cause. | Up to Week 24 |
| Cardiovascular Mortality | Number of participants who die due to cardiovascular-related causes. | Up to Week 24 |
Participants assigned to receive Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy, then Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy. |
| FG002 | Intervention Sequence K1K2B1B2 | Participants assigned to receive Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy, then Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy. |
| FG003 | Intervention Sequence K2K1B2B1 | Participants assigned to receive Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy, then Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Interventional Crossover Period 1 |
|
|
| Interventional Crossover Period 2 |
|
| Interventional Crossover Period 3 |
|
| Interventional Crossover Period 4 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Sequence B1B2K1K2 | Participants assigned to receive Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy, then Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy. |
| BG001 | Intervention Sequence B2B1K2K1 | Participants assigned to receive Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy, then Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy. |
| BG002 | Intervention Sequence K1K2B1B2 | Participants assigned to receive Potassium Removal Maximization Strategy, then Potassium Gradient Minimization Strategy, then Alkalosis Avoidance Strategy, then Acidosis Avoidance Strategy. |
| BG003 | Intervention Sequence K2K1B2B1 | Participants assigned to receive Potassium Gradient Minimization Strategy, then Potassium Removal Maximization Strategy, then Acidosis Avoidance Strategy, then Alkalosis Avoidance Strategy. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | Percentage of sessions | Up to Week 24 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Enrolled Per Month | Assessment of recruitment feasibility. | Posted | Number | Patients per month | Up to Week 24 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | Proportion of participants | Up to Week 24 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | 95% Confidence Interval | Proportion of participants | Up to Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | Seconds | Up to Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Posted | Mean | Standard Deviation | Percentage of sessions | Up to Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Duration of Atrial Fibrillation | Posted | Mean | Standard Deviation | Seconds | Up to Week 24 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Potentially Lethal Arrhythmias | Potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds. | Posted | Mean | Standard Deviation | Number of Potentially Lethal Arrhythmias | Up to Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Screened Patients Who Are Enrolled | Secondary feasibility measure to assess the size of the necessary screening pool. | Posted | Count of Participants | Participants | Up to Week 24 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Hospitalization | Posted | Number | Number of Hospitalizations | Up to Week 24 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | All-Cause Mortality | Number of participants who die due to any cause. | Posted | Count of Participants | Participants | Up to Week 24 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Cardiovascular Mortality | Number of participants who die due to cardiovascular-related causes. | Posted | Count of Participants | Participants | Up to Week 24 |
|
6 months
regular investigator assessment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Potassium Removal Maximization Strategy | 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. | 1 | 17 | 3 | 17 | 4 | 17 |
| EG001 | 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. | 0 | 16 | 3 | 16 | 3 | 16 |
| EG002 | 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. | 1 | 16 | 3 | 16 | 1 | 16 |
| EG003 | 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. | 2 | 17 | 5 | 17 | 3 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral Angiogram | Surgical and medical procedures | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperparathyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Illeostomy closure | Surgical and medical procedures | Systematic Assessment |
| ||
| Kidney stones | Renal and urinary disorders | Systematic Assessment |
| ||
| Sudden visual loss | Eye disorders | Systematic Assessment |
| ||
| Vascular access site complication | Vascular disorders | Systematic Assessment |
| ||
| Vascular access site complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abcess | Infections and infestations | Systematic Assessment |
| ||
| Athralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cramping | Vascular disorders | Systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Kidney stones | Renal and urinary disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Puncture wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular access site complication | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David M Charytan, MD, MSc | NYU Langone Health | 646-501-9086 | david.charytan@nyulangone.org |
| Jul 6, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
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. |
|
|
|
|
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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
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| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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