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Liberation From Acute Dialysis

Liberation From Acute Dialysis

Recruiting
18 years and older
All
Phase N/A

Overview

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.

Description

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).

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study details
    Renal Failure
    Renal Failure
    Acute renal failure
    Kidney; Disease
    Acute
    Dialysis Related Complication

NCT04218370

University of California, San Francisco

16 February 2024

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