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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
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The overall goal of this study is to evaluate the feasibility of conducting a randomized controlled trial comparing a standardized dialysis strategy versus usual care (dialysis prescription ordered by each patient's primary nephrologist) in patients with AKI-receiving dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized Dialysis and Structured Discontinuation (S2D2) | Experimental | Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation |
|
| Usual Care | Active Comparator | Dialysis prescription ordered by their primary nephrologist/intensivist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Dialysis and Structured Discontinuation (S2D2) | Other | Prescription to minimize dialysis-induced ischemia
Structured dialysis discontinuation (all criteria met)
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Recruitment of the target population to the RCT | 2 years |
| Fidelity | At least 80% of randomized participants remain in the trial and on the allocated study treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis-Free Days | The number of days that a patient did not need dialysis. A patient can only accrue dialysis-free days after the final dialysis session that commences the monitoring period for kidney recovery. Participants who die will be considered to have zero dialysis-free days. | 6-months |
| Hypotensive Event on Dialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia on Dialysis | Defined as new atrial (excluding sinus tachycardia or sinus arrhythmia) or ventricular arrhythmia that develops during RRT and was not present prior to the initiation of RRT | 6-months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel A Silver | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40232884 | Derived | McCoy IE, Liu KD, Ghamarian E, Quenot JP, Zarbock A, Bihorac A, Khoo B, Gallagher MP, Du B, Joannidis M, Kashani K, Tolwani A, Bagshaw SM, Wald R; STandard versus Accelerated initiation of Renal Replacement Therapy in AKI (STARRT-AKI) Investigators. Dialysis Dependence in Standard versus Accelerated Initiation of KRT in AKI: A Post Hoc Analysis. Clin J Am Soc Nephrol. 2025 May 1;20(5):601-607. doi: 10.2215/CJN.0000000672. Epub 2025 Mar 11. |
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Deidentified patient data will be available up to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
Up to 3 years after manuscript publication
Available to researchers with methodologically sound proposals approved by the principal investigator.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Usual Care | Other | Dialysis prescription ordered by their clinical team. Decisions on dialysis discontinuation will be left to individual clinicians and will not be guided by a standard protocol. |
|
Defined as a drop in blood pressure requiring one of:
|
| 6-months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |