Liberation From Acute Dialysis (LIBERATE-D)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Dialysis Related Complication; Acute Kidney Injury; Kidney; Disease, Acute

Treatments: Procedure: Dialysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04218370

R01DK122797 (U.S. NIH Grant/Contract)

LIBERATED

Details and patient eligibility

About

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.

Full 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).

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

Conventional

Active Comparator group

Description:

Thrice-weekly intermittent dialysis until pre-specified criteria for recovery are met

Treatment:

Procedure: Dialysis

Conservative

Experimental group

Description:

Conservative dialysis strategy--dialysis prescribed only when specific metabolic or clinical indications are met. These indications are: blood urea nitrogen \>112 mg/dL (40 mmol/L; blood potassium concentration \>6 mmol/L; blood potassium concentration \>5.5 mmol/L despite medical treatment; arterial blood gas pH \<7.15, or in the absence of an available blood gas, serum bicarbonate \<12 mmol/L, acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate \>5 L/min or equivalent via face mask/tracheostomy mask to maintain SpO2 \>95% or requiring FiO2 \>50% in patients with tracheostomy already on invasive or non-invasive mechanical ventilation and despite diuretic therapy; clinician judgement

Treatment:

Procedure: Dialysis