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NCT Number: NCT04218370

Liberation From Acute Dialysis

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.

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Key information

Conditions

Acute Kidney Injury Dialysis Related Complication Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney; Disease, Acute Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Califonia, San Francisco, San Francisco, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialysis

Procedure

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

Primary outcomes

  1. Proportion of patients with renal recovery at hospital discharge

    Time frame: 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 outcomes

  1. Number of dialysis sessions/week

    Time frame: Up to 28 days

    Number of dialysis sessions prescribed in each treatment arm, expressed per week.

  2. Dialysis-free days to study day 28

    Time frame: 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 outcomes

  1. Renal recovery at day 28

    Time frame: 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.

  2. Renal recovery

    Time frame: 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.

  3. All-cause in-hospital mortality

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

    Vital status at the time of hospital discharge

  4. All-cause day 28 mortality

    Time frame: Up to 28 days

    Vital status at day 28 after study enrollment

  5. All-cause day 90 mortality

    Time frame: Up to 90 days

    Vital status at day 90 after study enrollment

  6. Length of hospital stay

    Time frame: 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

  7. Time to renal recovery

    Time frame: Up to day 90

    Days after study enrollment before renal recovery occurs

  8. Pre-specified adverse events

    Time frame: Up to 28 days

    Adverse events that might be related to the dialysis intervention, including emergent dialysis sessions, intradialytic hypotension and post-dialysis hypotension

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)
  • Vanderbilt University Medical Center

Registry information

Acronym: LIBERATE-D

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2020
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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