Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

Acute Kidney Injury Clinical Trial

— Recover-AKI  

Official title:

Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948476
• Other study ID #: 6027699
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Queen's University
• Contact: Samuel A Silver
• Phone: 613-549-6666
• Email: samuel.silver[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• 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
• 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.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Samuel Silver	Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Recruitment	Recruitment of the target population to the RCT	2 years
Primary	Fidelity	At least 80% of randomized participants remain in the trial and on the allocated study treatment	2 years
Secondary	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
Secondary	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