Liberation From Acute Dialysis

Acute Kidney Injury Clinical Trial

— LIBERATE-D  

Official title:

LIBERation From AcuTE Dialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04218370
• Other study ID #: LIBERATED
• Secondary ID: R01DK122797
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Kathleen Liu, MD, PhD, MAS
• Phone: 4155027998
• Email: kathleen.liu[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Dialysis
Dialysis treatment, either in the form of hemodialysis or continuous renal replacement therapy (if patient develops hemodynamic instability)

Locations

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

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

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