Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI)

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Acute Kidney Injury

Treatments: Other: Conservative dialysis strategy; Other: TIW dialysis strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03305549

F32DK115030

Details and patient eligibility

About

The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy" in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. The overall hypothesis is that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks evidence of renal recovery and may actually delay or preclude recovery. The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.

Full description

The recent landmark Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed strategy for RRT initiation among patients with incident stage 3 AKI - in which RRT was delayed unless specific metabolic or clinical indications for RRT were present - was safe and averted the need for RRT in nearly half of the critically ill participants, in comparison to an early RRT initiation strategy. The hypothesis for this study is: for prevalent patients with established AKI-D, a conservative dialysis strategy - in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present - will shorten time to RRT-independence and improve the likelihood of renal recovery.

The RAD-AKI Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI) that will compare conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy." The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.

Enrollment: 16 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult inpatients with AKI-D due to acute tubular necrosis who have already initiated renal replacement therapy
• If initiated on CRRT, patients will be eligible only if they have already tolerated 1 intermittent hemodialysis (IHD) session at the research site.
• If transferred from an outside hospital, eligible patients must have tolerated 1 IHD session at the research site prior to enrollment.
• Not requiring vasopressor support
• Not intubated and not having a supplemental oxygen requirement of >5 L/min via nasal cannula
• Treating MDs (nephrology and primary team attendings) and patient (or legally authorized representative) consent to enrollment

Exclusion criteria

• Diagnosis of end-stage renal disease (ESRD) or chronic dialysis prior to hospitalization
• Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
• Liver transplant unit patients
• Patients who underwent kidney transplantation during index hospitalization
• Cause of AKI-D is complete nephrectomy
• Current pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

TIW Dialysis Strategy

Active Comparator group

Description:

Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.

Treatment:

Other: TIW dialysis strategy

Conservative Dialysis Strategy

Experimental group

Description:

Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present.

Treatment:

Other: Conservative dialysis strategy