LIBERATE-D: Liberation From Acute Dialysis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Conventional Thrice-weekly intermittent dialysis until pre-specified criteria for recovery are met |
Procedure: Dialysis
Dialysis treatment, either in the form of hemodialysis or continuous renal replacement therapy (if patient develops hemodynamic instability)
|
| 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 |
Procedure: Dialysis
Dialysis treatment, either in the form of hemodialysis or continuous renal replacement therapy (if patient develops hemodynamic instability)
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with renal recovery at hospital discharge [Up to 14 days after hospital discharge (to allow for ascertainment of outcome at hospital discharge, which requires a period of sustained dialysis independence)]
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.
Secondary Outcome Measures
- Number of dialysis sessions/week [Up to 28 days]
Number of dialysis sessions prescribed in each treatment arm, expressed per week.
- Dialysis-free days to study day 28 [Up to 28 days]
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.
Other Outcome Measures
- Renal recovery at day 28 [Up to 42 days (to allow for ascertainment of outcome at day 28, which requires a period of sustained dialysis independence)]
Alive and off dialysis at day 28, with sustained independence from dialysis for 14 days.
- Renal recovery [Up to 104 days (to allow for ascertainment of outcome at day 28, which requires a period of sustained dialysis independence)]
Alive and off dialysis at day 90, with sustained independence from dialysis for 14 days.
- All-cause in-hospital mortality [Up to date of death from any cause, assessed up to 12 months]
Vital status at the time of hospital discharge
- All-cause day 28 mortality [Up to 28 days]
Vital status at day 28 after study enrollment
- All-cause day 90 mortality [Up to 90 days]
Vital status at day 90 after study enrollment
- Length of hospital stay [Up to date of hospital discharge or death from any cause, whichever comes first, assessed up to 12 months]
Duration of hospital stay after study enrollment
- Time to renal recovery [Up to day 90]
Days after study enrollment before renal recovery occurs
- Pre-specified adverse events [Up to 28 days]
Adverse events that might be related to the dialysis intervention, including emergent dialysis sessions, intradialytic hypotension and post-dialysis hypotension
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Califonia, San Francisco | San Francisco | California | United States | 94143 |
| 2 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37212 |
Sponsors and Collaborators
- University of California, San Francisco
- Vanderbilt University Medical Center
- National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Kathleen Liu, MD, PhD, MAS, University of California, San Francisco
- Principal Investigator: Chi-yuan Hsu, MD, MSc, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LIBERATED
- R01DK122797