Liberation From Acute Dialysis

NCT04218370 | Completed DMC

• 2 other identifiers: LIBERATEDR01DK122797
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of dialysis sessions/week

  Up to 28 days

• Dialysis-free days to study day 28

  Up to 28 days

Other Outcomes (8)

• 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)

• Renal recovery

  Up to 104 days (to allow for ascertainment of outcome at day 28, which requires a period of sustained dialysis independence)

• All-cause in-hospital mortality

  Up to date of death from any cause, assessed up to 12 months

Study Arms (2)

Conventional

ACTIVE COMPARATOR

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

Procedure: Dialysis

Conservative

EXPERIMENTAL

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

Interventions

Dialysis PROCEDURE

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

Conservative; Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Vanderbilt University Medical Center: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (4)

University of Califonia, San Francisco

San Francisco, California, 94143, United States

Location

Washington University in St Louis/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Related Publications (2)

• Liu KD, Siew ED, Tuot DS, Vijayan A, Matzumura Umemoto G, Birkelo BC, Lee BJ, Kwong YD, McCoy IE, Delucchi K, Zhuo H, Hsu CY. A Conservative Dialysis Strategy and Kidney Function Recovery in Dialysis-Requiring Acute Kidney Injury: The Liberation From Acute Dialysis (LIBERATE-D) Randomized Clinical Trial. JAMA. 2026 Jan 27;335(4):326-335. doi: 10.1001/jama.2025.21530.

  PMID: 41201895 DERIVED

• McCoy IE, Liu KD, Ghamarian E, Quenot JP, Zarbock A, Bihorac A, Khoo B, Gallagher MP, Du B, Joannidis M, Kashani K, Tolwani A, Bagshaw SM, Wald R; STandard versus Accelerated initiation of Renal Replacement Therapy in AKI (STARRT-AKI) Investigators. Dialysis Dependence in Standard versus Accelerated Initiation of KRT in AKI: A Post Hoc Analysis. Clin J Am Soc Nephrol. 2025 May 1;20(5):601-607. doi: 10.2215/CJN.0000000672. Epub 2025 Mar 11.

  PMID: 40232884 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Disease

Interventions

Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Kathleen Liu, MD, PhD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Chi-yuan Hsu, MD, MSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 6, 2020
• Study Start: January 23, 2020
• Primary Completion: June 8, 2025
• Study Completion: June 8, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)