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Liberation From Acute Dialysis (LIBERATE-D)

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dialysis

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Califonia, San FranciscoRecruiting
Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional

Conservative

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of dialysis sessions/week

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

Dialysis-free days to study day 28

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.

Full Information

NCT ID

NCT04218370

First Posted

December 19, 2019

Last Updated

October 31, 2022

Sponsor

University of California, San Francisco

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04218370

Brief Title

Liberation From Acute Dialysis

Acronym

LIBERATE-D

Official Title

LIBERation From AcuTE Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 23, 2020 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional

Arm Type

Active Comparator

Arm Description

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

Arm Title

Conservative

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Dialysis

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of patients with renal recovery at hospital discharge

Description

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.

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)

Secondary Outcome Measure Information:

Title

Number of dialysis sessions/week

Description

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

Time Frame

Up to 28 days

Title

Dialysis-free days to study day 28

Description

Time Frame

Up to 28 days

Other Pre-specified Outcome Measures:

Title

Renal recovery at day 28

Description

Alive and off dialysis at day 28, with sustained independence from dialysis for 14 days.

Time Frame

Up to 42 days (to allow for ascertainment of outcome at day 28, which requires a period of sustained dialysis independence)

Title

Renal recovery

Description

Alive and off dialysis at day 90, with sustained independence from dialysis for 14 days.

Time Frame

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

Title

All-cause in-hospital mortality

Description

Vital status at the time of hospital discharge

Time Frame

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

Title

All-cause day 28 mortality

Description

Vital status at day 28 after study enrollment

Time Frame

Up to 28 days

Title

All-cause day 90 mortality

Description

Vital status at day 90 after study enrollment

Time Frame

Up to 90 days

Title

Length of hospital stay

Description

Duration of hospital stay after study enrollment

Time Frame

Up to date of hospital discharge or death from any cause, whichever comes first, assessed up to 12 months

Title

Time to renal recovery

Description

Days after study enrollment before renal recovery occurs

Time Frame

Up to day 90

Title

Pre-specified adverse events

Description

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

Time Frame

Up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kathleen Liu, MD, PhD, MAS

Phone

4155027998

kathleen.liu@ucsf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Chi-yuan Hsu, MD, MSc

Phone

4153532379

chi-yuan.hsu@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen Liu, MD, PhD, MAS

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chi-yuan Hsu, MD, MSc

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Califonia, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathleen Liu, MD, PhD, MAS

Phone

415-502-7998

kathleen.liu@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Chi-yuan Hsu, MD, MSc

Phone

415-353-2379

chi-yuan.hsu@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Kathleen Liu, MD, PhD, MAS

First Name & Middle Initial & Last Name & Degree

Chi-yuan Hsu, MD, MSc

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edward Siew, MD

Phone

615-343-1279

edward.siew@vumc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Liberation From Acute Dialysis

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