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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK122797 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | Thrice-weekly intermittent dialysis until pre-specified criteria for recovery are met |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialysis | Procedure | Dialysis treatment, either in the form of hemodialysis or continuous renal replacement therapy (if patient develops hemodynamic instability) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of dialysis sessions/week | Number of dialysis sessions prescribed in each treatment arm, expressed per week. | Up to 28 days |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Renal recovery at day 28 | Alive and off dialysis at day 28, with sustained independence from dialysis for 14 days. | Up to 42 days (to allow for ascertainment of outcome at day 28, which requires a period of sustained dialysis independence) |
| Renal recovery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Liu, MD, PhD, MAS | University of California, San Francisco | Principal Investigator |
| Chi-yuan Hsu, MD, MSc | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Califonia, San Francisco | San Francisco | California | 94143 | United States | ||
| Washington University in St Louis/Barnes-Jewish Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41201895 | Derived | 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. | |
| 40232884 | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D004194 | Disease |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003956 | Dialysis |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |
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| Up to 28 days |
Alive and off dialysis at day 90, with sustained independence from dialysis for 14 days.
| 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 | Vital status at the time of hospital discharge | Up to date of death from any cause, assessed up to 12 months |
| All-cause day 28 mortality | Vital status at day 28 after study enrollment | Up to 28 days |
| All-cause day 90 mortality | Vital status at day 90 after study enrollment | Up to 90 days |
| Length of hospital stay | Duration of hospital stay after study enrollment | Up to date of hospital discharge or death from any cause, whichever comes first, assessed up to 12 months |
| Time to renal recovery | Days after study enrollment before renal recovery occurs | Up to day 90 |
| Pre-specified adverse events | Adverse events that might be related to the dialysis intervention, including emergent dialysis sessions, intradialytic hypotension and post-dialysis hypotension | Up to 28 days |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |