Liberation From Acute Dialysis

STATUS

Recruiting
participants needed

220
sponsor

University of California, San Francisco

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Updated on 19 February 2024

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vasopressor

acute renal failure

dialysis

glomerular filtration rate

renal injury

liberate

vasoconstrictor

renal replacement

acute tubular necrosis

intermittent hemodialysis

acute renal disease

injury kidney

Summary

Show definitions

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.

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).

Details

Condition	Renal Failure, Renal Failure, Acute renal failure, Kidney; Disease, Acute, Dialysis Related Complication
Age	18years - 100years
Treatment	Dialysis
Clinical Study Identifier	NCT04218370
Sponsor	University of California, San Francisco
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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

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Liberation From Acute Dialysis