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Summary

for people ages 18–100 (full criteria)
at San Francisco, California
study started
estimated completion:

Description

Summary

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.

Official Title

Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study

Details

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.

Keywords

Acute Kidney Injury Dialysis-requiring Acute Kidney Injury Renal Recovery Wounds and Injuries

Eligibility

You can join if…

Open to people ages 18–100

  • 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

You CAN'T join if...

  • 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

Location

  • UCSF Medical Center Moffitt-Long Hospital
    San Francisco, California, 94143, United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03305549
Lead Scientists
Benjamin Lee
Chi-yuan Hsu
Kathleen Liu
Study Type
Interventional
Last Updated
October 28, 2017