Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-12

Study Completion Date

2024-12-20

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.

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Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standardized Dialysis and Structured Discontinuation (S2D2)

Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation

Group Type EXPERIMENTAL

Standardized Dialysis and Structured Discontinuation (S2D2)

Intervention Type OTHER

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

Usual Care

Dialysis prescription ordered by their primary nephrologist/intensivist.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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Standardized Dialysis and Structured Discontinuation (S2D2)

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

Intervention Type OTHER

Usual Care

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.

Intervention Type OTHER

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

1. Receipt of dialysis for ≥90 days
2. Known baseline estimated glomerular filtration rate (eGFR) \<15mL/min/1.73m2
3. 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
4. Receipt of any dialysis prior to the current admission within the past 2 months
5. Kidney transplant within the past 12 months
6. Pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No