Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Kathleen Liu, MD, PhD, MASChi-yuan Hsu, MD, MSc
Photo of Kathleen Liu
Kathleen Liu
Photo of Chi-yuan Hsu
Chi-yuan Hsu

Description

Summary

The goal of the LIBERATE-D clinical trial is to improve outcomes for patients recovering from dialysis-requiring acute kidney injury (AKI-D). The impact of a conservative dialysis strategy compared to standard clinical practice of thrice-weekly dialysis will be examined to help generate knowledge for how to guide delivery of dialysis to facilitate renal recovery.

Official Title

LIBERation From AcuTE Dialysis

Details

Dialysis-requiring acute kidney injury (AKI-D) is a devastating complication among hospitalized patients for which there are no treatments other than supportive care. Recovery of sufficient renal function to stop dialysis is an unequivocally important clinical and patient-oriented outcome. Shortening dialysis duration and increasing the number of AKI-D patients who recover would have a major clinical, public health and cost-saving impact. However, there is currently no evidence to guide the delivery of dialysis to facilitate recovery. The investigators hypothesize that in patients who have AKI-D and who are hemodynamically stable, a conservative dialysis strategy--in which hemodialysis is not continued unless specific metabolic or clinical indications for renal replacement therapy (RRT) are present--will improve the likelihood of renal recovery compared with the current standard clinical practice of thrice-weekly intermittent dialysis. The investigators have conducted a pilot clinical trial to demonstrate the feasibility of this approach. The investigators propose here a 2-center randomized controlled trial to test a conservative dialysis strategy in a larger AKI-D population (N = 220).

Keywords

Acute Kidney Injury Kidney; Disease, Acute Dialysis Related Complication Acute Disease Dialysis Conservative

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥ 18 years of age
  • Inpatient with AKI-D (intermittent hemodialysis or continuous renal replacement therapy received on at least one calendar day) at least partially due t acute tubular necrosis per the clinical nephrology team
  • Hemodynamic stability: not requiring vasopressor support and with planned intermittent dialysis
  • Baseline estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m2

You CAN'T join if...

  • Nontraditional indication for dialysis (end-stage liver disease awaiting transplantation, fulminant hepatic failure, intoxication)
  • Complete nephrectomy as cause of AKI-D
  • Kidney transplant during index hospitalization
  • Dialysis > 3 months
  • Decompensated heart failure requiring left ventricular assist device or continuous inotropic support
  • Mechanical ventilation via endotracheal tube
  • Hypoxemia requiring significant oxygen support: >5 liters/min via nasal cannula or equivalent via face mask/tracheostomy mask to maintain oxygen saturation > 95%, or requiring fraction of inspired oxygen >50% in patients with tracheostomy requiring invasive or non-invasive ventilation
  • Unable to consent and no surrogate decisionmaker available
  • Pregnant
  • Prisoner
  • Clinical team declines to allow study participation

Locations

  • University of Califonia, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Vanderbilt University Medical Center not yet accepting patients
    Nashville Tennessee 37212 United States

Lead Scientists at UCSF

  • Kathleen Liu, MD, PhD, MAS
    EDUCATION College: Harvard University, AB Medical/Graduate School: University of California, San Francisco, MD, PhD RESEARCH My current research areas of interest focus on the predictive and pathogenetic role of biomarkers for both acute and chronic disease states.
  • Chi-yuan Hsu, MD, MSc
    Dr. Hsu has been Chief of the Division of Nephrology at UCSF Health since 2007. His research spans acute, chronic and end-stage kidney disease and includes both observational studies and clinical trials. Collapse Interestsacute, chronic and end-stage renal disease, hypertension

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04218370
Study Type
Interventional
Last Updated