search
Back to results

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

Primary Purpose

Acute Kidney Injury

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standardized Dialysis and Structured Discontinuation (S2D2)
Usual Care
Sponsored by
Samuel Silver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kingston Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standardized Dialysis and Structured Discontinuation (S2D2)

Usual Care

Arm Description

Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation

Dialysis prescription ordered by their primary nephrologist/intensivist.

Outcomes

Primary Outcome Measures

Recruitment
Recruitment of the target population to the RCT
Fidelity
At least 80% of randomized participants remain in the trial and on the allocated study treatment

Secondary Outcome Measures

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.
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

Full Information

First Posted
June 24, 2021
Last Updated
April 28, 2022
Sponsor
Samuel Silver
Collaborators
Unity Health Toronto
search

1. Study Identification

Unique Protocol Identification Number
NCT04948476
Brief Title
Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis
Acronym
Recover-AKI
Official Title
Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samuel Silver
Collaborators
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standardized Dialysis and Structured Discontinuation (S2D2)
Arm Type
Experimental
Arm Description
Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Dialysis prescription ordered by their primary nephrologist/intensivist.
Intervention Type
Other
Intervention Name(s)
Standardized Dialysis and Structured Discontinuation (S2D2)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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 Outcome Measure Information:
Title
Recruitment
Description
Recruitment of the target population to the RCT
Time Frame
2 years
Title
Fidelity
Description
At least 80% of randomized participants remain in the trial and on the allocated study treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Dialysis-Free Days
Description
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
Title
Hypotensive Event on Dialysis
Description
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
Other Pre-specified Outcome Measures:
Title
Arrhythmia on Dialysis
Description
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
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel A Silver
Phone
613-549-6666
Email
samuel.silver@queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel A Silver
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel A Silver
Email
samuel.silver@queensu.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

We'll reach out to this number within 24 hrs