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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This will be a randomized controlled pilot trial comparing usual care to a precision approach to dialysis potassium prescribing. The precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision approach to K Prescription for HD (PKRxHD) | Experimental | Participants will receive a novel dialysate potassium (K) management strategy. |
|
| Usual Care | Active Comparator | Standard dialysis potassium prescribing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PKRxHD | Other | The precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD). |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Adherence | Measured as the proportion of hemodialysis (HD) treatments in the experimental arm completed per protocol with both pre-HD point of care testing and appropriate adjustment of the dialysate prescription. | Up to Week 24 |
| Recruitment Feasibility | Measured as the proportion of eligible patients enrolled successfully. | Baseline |
| Incidence Rate of Pre-HD Hyperkalemia | Hyperkalemia is defined as K≥ 6.4 mEq/L. | Baseline |
| Post-HD Recovery Time | Measured as the average time to recovery following each HD session. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Post-HD Hyperkalemia Incidence Rate | Hyperkalemia is defined as K≥ 6.4 mEq/L. | Up to Week 24 |
| Incidence Rate of Moderate Hyperkalemia | Hyperkalemia is defined as K≥ 3.0 mEq/L. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Charytan, MD | Contact | 212-263-0705 | David.Charytan@nyulangone.org | |
| Zoe Rimler | Contact | 212-263-2544 | Zoe.Rimler@nyulangone.org |
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The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.Charytan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D003956 | Dialysis |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |
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| Dialysis | Procedure | Standard of care dialysis. |
|
| Up to Week 24 |
| Incidence Rate of Peri-Dialytic Cramping | Up to Week 24 |
| Incidence Rate of Intradialytic Hypotension | Intradialytic hypotension will be defined as the proportion of HD sessions with intradialytic systolic blood pressure<90 mmHg, as this definition best captures associations with mortality according to current guidelines. | Up to Week 24 |
| 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 |