Acute Kidney Injury Clinical Trial
— LIBERATE-DOfficial title:
LIBERation From AcuTE Dialysis
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.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Intermountain Medical Center | Murray | Utah |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Washington University in St Louis/Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | University of Califonia, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Renal recovery at day 28 | Alive and off dialysis at day 28, with sustained independence from dialysis for 14 days. | Up to 42 days (to allow for ascertainment of outcome at day 28, which requires a period of sustained dialysis independence) | |
Other | Renal recovery | Alive and off dialysis at day 90, with sustained independence from dialysis for 14 days. | Up to 104 days (to allow for ascertainment of outcome at day 28, which requires a period of sustained dialysis independence) | |
Other | All-cause in-hospital mortality | Vital status at the time of hospital discharge | Up to date of death from any cause, assessed up to 12 months | |
Other | All-cause day 28 mortality | Vital status at day 28 after study enrollment | Up to 28 days | |
Other | All-cause day 90 mortality | Vital status at day 90 after study enrollment | Up to 90 days | |
Other | Length of hospital stay | Duration of hospital stay after study enrollment | Up to date of hospital discharge or death from any cause, whichever comes first, assessed up to 12 months | |
Other | Time to renal recovery | Days after study enrollment before renal recovery occurs | Up to day 90 | |
Other | Pre-specified adverse events | Adverse events that might be related to the dialysis intervention, including emergent dialysis sessions, intradialytic hypotension and post-dialysis hypotension | Up to 28 days | |
Primary | Proportion of patients with renal recovery at hospital discharge | Alive and off dialysis at the time of discharge, with sustained independence from dialysis for 14 days. This outcome does not require that all 14 days of sustained independence occur in-hospital. | Up to 14 days after hospital discharge (to allow for ascertainment of outcome at hospital discharge, which requires a period of sustained dialysis independence) | |
Secondary | Number of dialysis sessions/week | Number of dialysis sessions prescribed in each treatment arm, expressed per week. | Up to 28 days | |
Secondary | Dialysis-free days to study day 28 | The number of days that a patient did not need dialysis to study day 28. A patient can only accrue dialysis-free days after the final dialysis session that commences the monitoring period for renal recovery. Subjects who die before study day 28 will be considered to have zero dialysis-free days. | Up to 28 days |
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