Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis (Recover-AKI)

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 Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Standardized Dialysis and Structured Discontinuation (S2D2); Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized Dialysis and Structured Discontinuation (S2D2); Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation	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
Active Comparator: Usual Care; Dialysis prescription ordered by their primary nephrologist/intensivist.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Samuel Silver
• Collaborators: Unity Health Toronto
• Investigators: Principal Investigator: Samuel A Silver, Kingston Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries
• Other Study ID Numbers: 6027699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified patient data will be available up to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
• IPD Sharing Time Frame: Up to 3 years after manuscript publication
• IPD Sharing Access Criteria: Available to researchers with methodologically sound proposals approved by the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No