Acute Kidney InjuryRecover-AKINCT04948476
Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis
A study testing Standardized Dialysis and Structured Discontinuation (S2D2) in people with Acute Kidney Injury, run by Samuel Silver at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Standardized Dialysis and Structured Discontinuation (S2D2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 12 Apr 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received ≥2 sessions of any dialysis modality for presumed AKI
- Plans for continued intermittent hemodialysis or sustained low efficiency dialysis treatments
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Kidney Injury
- Being tested
- Standardized Dialysis and Structured Discontinuation (S2D2), Usual Care
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Dialysis and Structured Discontinuation (S2D2) | Experimental | Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation Receives: Other: Standardized Dialysis and Structured Discontinuation (S2D2) |
| Usual Care | Active comparator | Dialysis prescription ordered by their primary nephrologist/intensivist. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment of the target population to the RCT
Measured: 2 years
Fidelity
At least 80% of randomized participants remain in the trial and on the allocated study treatment
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 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
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start12 Apr 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Silver
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor-investigator, Samuel Silver, Queen's University
- Investigators
- Samuel A Silver, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948476
- Sponsor's protocol ID
- 6027699
- Acronym
- Recover-AKI
- Status last verified
- Feb 2025
- First submitted
- 24 Jun 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified patient data will be available up to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
Publications
McCoy IE, Liu KD, Ghamarian E, Quenot JP, Zarbock A, Bihorac A, Khoo B, Gallagher MP, Du B, Joannidis M, Kashani K, Tolwani A, Bagshaw SM, Wald R; STandard versus Accelerated initiation of Renal Replacement Therapy in AKI (STARRT-AKI) Investigators. Dialysis Dependence in Standard versus Accelerated Initiation of KRT in AKI: A Post Hoc Analysis. Clin J Am Soc Nephrol. 2025 May 1;20(5):601-607. doi: 10.2215/CJN.0000000672. Epub 2025 Mar 11.
PubMed 40232884
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis
- ClinicalTrials.gov ID
- NCT04948476
- Acronym / sponsor ID
- Recover-AKI / 6027699
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Samuel SilverUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Dialysis and Structured Discontinuation (S2D2) | Experimental | Other: Standardized Dialysis and Structured Discontinuation (S2D2)Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation |
| Usual Care | Active comparator | Other: Usual CareDialysis prescription ordered by their primary nephrologist/intensivist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Received ≥2 sessions of any dialysis modality for presumed AKI
- Plans for continued intermittent hemodialysis or sustained low efficiency dialysis treatments
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Standardized Dialysis and Structured Discontinuation (S2D2) |
| Usual CareDialysis 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. | Other | Usual Care |
Primary outcome
Recruitment
Time frame: 2 years
Recruitment of the target population to the RCT
Fidelity
Time frame: 2 years
At least 80% of randomized participants remain in the trial and on the allocated study treatment
2 secondary outcomes
Dialysis-Free Days
Time frame: 6-months
Hypotensive Event on Dialysis
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 40232884McCoy IE, Liu KD, Ghamarian E, Quenot JP, Zarbock A, Bihorac A, Khoo B, Gallagher MP, Du B, Joannidis M, Kashani K, Tolwani A, Bagshaw SM, Wald R; STandard versus Accelerated initiation of Renal Replacement Therapy in AKI (STARRT-AKI) Investigators. Dialysis Dependence in Standard versus Accelerated Initiation of KRT in AKI: A Post Hoc Analysis. Clin J Am Soc Nephrol. 2025 May 1;20(5):601-607. doi: 10.2215/CJN.0000000672. Epub 2025 Mar 11.
- Individual participant dataSharing planned: Yes. Deidentified patient data will be available up to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel A Silver principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Dialysis and Structured Discontinuation (S2D2) in people with Acute Kidney Injury, run by Samuel Silver at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04948476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.