Abstract
BackgroundCritically ill patients frequently develop acute kidney injury that necessitates renal replacement therapy (RRT). At some centers, critically ill patients who are hemodynamically unstable and require RRT are treated with slow low-efficiency dialysis (SLED). Unfortunately, hypotension is a frequent complication that occurs during SLED treatments and may limit the recovery of kidney function. Hypotension may also limit the amount of fluid that can be removed by ultrafiltration with SLED. Fluid overload can be exacerbated as a consequence, and fluid overload is associated with increased mortality.Occasionally, intravenous albumin fluid is given to prevent or treat low blood pressure during SLED. The intent of doing so is to increase the colloid oncotic pressure in the circulation to draw in extravascular fluid, increase the blood pressure, and enable more aggressive fluid removal with ultrafiltration. Nonetheless, there is little evidence to support this practice and theoretical reasons why it may not be especially effective at augmenting fluid removal in critically ill patients. At the same time, albumin fluid is expensive.As such, we present a protocol for a study to assess the feasibility of a randomized controlled trial evaluating the use of albumin fluid versus saline in critically ill patients receiving SLED.MethodsThis study is a single-center, double-blind, and randomized controlled pilot trial with two parallel arms. It involves randomly assigning patients receiving SLED treatment in the ICU to receive either albumin (25%) boluses or normal saline fluid boluses (placebo) to prevent and treat low blood pressure.DiscussionThe results of this pilot trial will help with planning a larger trial comparing the efficacy of the interventions in achieving fluid removal in critically ill patients with AKI on SLED. They will establish whether enough participants would participate in a larger study and accept the study procedures.Trial registrationThis trial is registered on ClinicalTrials.gov Identifier NCT03665311, registered on September 11, 2018.
Highlights
Ill patients frequently develop acute kidney injury that necessitates renal replacement therapy (RRT)
Efforts to optimize the administration of RRT hold promise for reducing mortality and maximizing the likelihood of renal recovery [5]
Study population and timeline The research coordinators will screen daily for patients that are in Intensive care unit (ICU) to determine whether or not a patient is Outcome measures Feasibility Recruitment rate, adherence to intervention, and completeness of follow-up are the principal outcome measures
Summary
Ill patients frequently develop acute kidney injury that necessitates renal replacement therapy (RRT). The clinical response to hemodynamic instability during slow low-efficiency dialysis (SLED) (or any form of RRT) is often to give intravenous fluid boluses (including albumin (25%)), reduce the ultrafiltration rate, or stop treatment altogether [6, 7] All of these interventions lead to a more positive net fluid balance in patients with RRT-requiring AKI who usually have minimal urine output. It is unclear if giving fluids in this situation (often with the view to allow further ultrafiltration later on during the same treatment) is beneficial given that (a) reducing the ultrafiltration rate alone may lead to adequate time for vascular refilling from the extravascular compartment to improve hemodynamics [6,7,8] and (b) hemodynamic instability may be unrelated to ultrafiltration/preload reduction [9,10,11]. This is important given mounting evidence that greater fluid overload in this context is an independent risk factor for increased mortality and longer term dialysis dependence [12–18]
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