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LIBERation From AcuTE Dialysis


Description

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.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 stab

Trial 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 * Anticipated discharge or transfer from study hospital within 48 hours

Study Info

Organization

University of California, San Francisco


Primary Outcome

Proportion of patients with renal recovery at hospital discharge


Outcome Timeframe Up to 14 days after hospital discharge (to allow for ascertainment of outcome at hospital discharge, which requires a period of sustained dialysis independence)

NCTID NCT04218370

Phases NA

Primary Purpose TREATMENT

Start Date 2020-01-23

Completion Date 2024-06-30

Enrollment Target 220

Interventions

PROCEDURE Dialysis

Locations Recruiting

University of Califonia, San Francisco

United States, California, San Francisco


Washington University in St Louis/Barnes-Jewish Hospital

United States, Missouri, Saint Louis


Vanderbilt University Medical Center

United States, Tennessee, Nashville


Intermountain Medical Center

United States, Utah, Murray


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