Acute Kidney Injury
Conditions
Brief summary
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.
Interventions
OTHERStandardized 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
OTHERUsual 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.
Sponsors
Unity Health Toronto
Samuel Silver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 2 years | Recruitment of the target population to the RCT |
| Fidelity | 2 years | At least 80% of randomized participants remain in the trial and on the allocated study treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis-Free Days | 6-months | 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. |
| Hypotensive Event on Dialysis | 6-months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia on Dialysis | 6-months | 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 |
Countries
Canada
Outcome results
None listed