Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Other: Usual Care; Other: Standardized Dialysis and Structured Discontinuation (S2D2)

• Registration Number: NCT04948476
• Lead Sponsor: Samuel Silver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-02
• Study Start: 2022-04-12
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Dialysis prescription ordered by their primary nephrologist/intensivist.
Standardized Dialysis and Structured Discontinuation (S2D2)	Standardized Dialysis and Structured Discontinuation (S2D2)	Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation

Primary Outcome Measures

Name	Time	Method
Recruitment	2 years	Recruitment of the target population to the RCT
Fidelity	2 years	At least 80% of randomized participants remain in the trial and on the allocated study treatment

Secondary Outcome Measures

Name	Time	Method
Dialysis-Free Days	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.
Hypotensive Event on Dialysis	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

Trial Locations

Locations (1)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada