Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Kathleen Liu, MD, PhD, MASChi-yuan Hsu, MD, MSc

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

Lead Scientists

  • 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
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04218370
Study Type
Interventional
Last Updated