Liberation From Acute Dialysis
Purpose
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.
Conditions
- Acute Kidney Injury
- Kidney; Disease, Acute
- Dialysis Related Complication
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Conventional |
Thrice-weekly intermittent dialysis until pre-specified criteria for recovery are met |
|
|
Experimental Conservative |
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 |
|
Recruiting Locations
Nashville, Tennessee 37212
More Details
- Status
- Recruiting
- Sponsor
- University of California, San Francisco
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).