Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

NCT04948476 | Completed DMC

• 1 other identifier: 6027699
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Dialysis-Free Days

  6-months

• Hypotensive Event on Dialysis

  6-months

Other Outcomes (1)

• Arrhythmia on Dialysis

  6-months

Study Arms (2)

Standardized Dialysis and Structured Discontinuation (S2D2)

EXPERIMENTAL

Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation

Other: Standardized Dialysis and Structured Discontinuation (S2D2)

Usual Care

ACTIVE COMPARATOR

Dialysis prescription ordered by their primary nephrologist/intensivist.

Other: Usual Care

Interventions

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

Standardized Dialysis and Structured Discontinuation (S2D2)

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received ≥2 sessions of any dialysis modality for presumed AKI
• Plans for continued intermittent hemodialysis or sustained low efficiency dialysis treatments

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Silver: lead
• Unity Health Toronto: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

• 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.

  PMID: 40232884 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Samuel A Silver

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Samuel A Silver

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 2, 2021
• Study Start: April 12, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Up to 3 years after manuscript publication
• Access Criteria: Available to researchers with methodologically sound proposals approved by the principal investigator.

Locations

CA (1)