Clinical trial NCT04218370: Liberation From Acute Dialysis
Official title: LIBERation From AcuTE Dialysis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Kidney; Disease, Acute
Dialysis Related Complication
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-01-06
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 criteria: 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

Primary outcomes:
measure: Proportion of patients with renal recovery at hospital discharge
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)
Secondary outcomes:
measure: Number of dialysis sessions/week
timeFrame: Up to 28 days
measure: Dialysis-free days to study day 28
timeFrame: Up to 28 days
Other outcomes:
measure: Renal recovery at day 28
timeFrame: Up to 42 days (to allow for ascertainment of outcome at day 28, which requires a period of sustained dialysis independence)
measure: Renal recovery
timeFrame: Up to 104 days (to allow for ascertainment of outcome at day 28, which requires a period of sustained dialysis independence)
measure: All-cause in-hospital mortality
timeFrame: Up to date of death from any cause, assessed up to 12 months
measure: All-cause day 28 mortality
timeFrame: Up to 28 days
measure: All-cause day 90 mortality
timeFrame: Up to 90 days
measure: Length of hospital stay
timeFrame: Up to date of hospital discharge or death from any cause, whichever comes first, assessed up to 12 months
measure: Time to renal recovery
timeFrame: Up to day 90
measure: Pre-specified adverse events
timeFrame: Up to 28 days
Locations:
city: San Francisco
country: United States
facility: University of Califonia, San Francisco
state: California
city: Saint Louis
country: United States
facility: Washington University in St Louis/Barnes-Jewish Hospital
state: Missouri
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: University of California, San Francisco
name: Kathleen Liu, MD, PhD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Chi-yuan Hsu, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: