Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

Samuel Silver110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Acute Kidney Injury

Interventions

Standardized Dialysis and Structured Discontinuation (S2D2)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 CareOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Outcomes

Primary Outcomes

Recruitment

Recruitment of the target population to the RCT

Time frame: 2 years

Fidelity

At least 80% of randomized participants remain in the trial and on the allocated study treatment

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 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

Time frame: 6-months

Data from ClinicalTrials.gov

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