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Completed

NCT Number: NCT04948476

Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

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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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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 Care

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.

Primary outcomes

  1. Recruitment

    Time frame: 2 years

    Recruitment of the target population to the RCT

  2. Fidelity

    Time frame: 2 years

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

Secondary outcomes

  1. Dialysis-Free Days

    Time frame: 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.

  2. Hypotensive Event on Dialysis

    Time frame: 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 outcomes

  1. Arrhythmia on Dialysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Samuel Silver

Other

Collaborators

  • Unity Health Toronto

Registry information

Acronym: Recover-AKI

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 2, 2021
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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