Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

Study Overview
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Brief Summary
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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.

Official Title
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Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: Standardized Dialysis and Structured Discontinuation (S2D2)
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received ≥2 sessions of any dialysis modality for presumed AKI Plans for continued intermittent hemodialysis or sustained low efficiency dialysis treatments Exclusion Criteria: Receipt of dialysis for ≥90 days Known baseline estimated glomerular filtration rate (eGFR) <15mL/min/1.73m2 Strong clinical suspicion of urinary tract obstruction, rapidly progressive glomerulonephritis (RPGN), vasculitis, thrombotic microangiopathy (TMA), myeloma related cast nephropathy, or acute interstitial nephritis (AIN) as the underlying cause of AKI Receipt of any dialysis prior to the current admission within the past 2 months Kidney transplant within the past 12 months Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized Dialysis and Structured Discontinuation (S2D2)<br>Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation | Other: Standardized Dialysis and Structured Discontinuation (S2D2)<br>* Prescription to minimize dialysis-induced ischemia Cool dialysate (35.0◦C) Dialysate sodium of 145mmol/L Dialysate calcium of 1.5mmol/L Maximum ultrafiltration rate of 10mL/kg/hour (if no weight, maximum is 500mL/hour) Note: If dialysis machines cannot get to the specified values, values closest to these are acceptable. Structured dialysis discontinuation (all criteria met) Most recent pre-dialysis potassium <6mmo/L and bicarbonate >12mmol/L Most recent urine volume ≥1L/day OR last ultrafiltration on dialysis <1L/session If available, timed urine collection with result for mean creatinine and/or urea clearance >12mL/min<br>|
| Active Comparator: Usual Care<br>Dialysis prescription ordered by their primary nephrologist/intensivist. | Other: Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Defined as a drop in blood pressure requiring one of: Initiation of a vasopressor during renal replacement therapy (RRT) session, OR, Premature discontinuation of RRT session due to blood pressure drop, OR, Any other intervention to stabilize blood pressure during the dialysis session as noted in the nursing record | 6-months |