Objective: The primary aim of this 60 patient feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol.
Background: Intravenous albumin (25%) boluses are frequently given to critically ill patients during slow low-efficiency dialysis (SLED) treatments for acute kidney injury (AKI). The intention of giving albumin during SLED is to stabilize the blood pressure to permit more aggressive overall fluid removal with ultrafiltration; however, there is little evidence to support this expensive practice. Objective: The primary aim of this feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol. The results of this feasibility trial will help us to plan and carry out a multicentre pilot trial comparing the efficacy of the interventions in achieving fluid removal in critically ill patients with AKI on SLED. Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of a Canadian tertiary care hospital. Study Population: 60 patients with AKI requiring treatment with SLED (by definition, Kidney Disease Improving Global Outcomes (KDIGO) stage 3 AKI). Intervention: Participants will be randomized to receive either albumin (25%) boluses or normal saline placebo boluses during their SLED treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
25% Albumin fluid (100 mL)
0.9% Normal Saline (100 mL)
The Ottawa Hospital
Ottawa, Ontario, Canada
Recruitment rate
Percentage of eligible patients that are successfully recruited into the study
Time frame: 24 months
Adherence to intervention
Percentage of SLED sessions in which patients received their allocated intervention (or placebo).
Time frame: Through study completion, on average 1 year.
Completeness of follow-up
Percentage of patients who have complete data available with respect to the primary and other secondary outcomes at the end of the study.
Time frame: 24 months
Volume removal achieved during SLED sessions
Overall fluid removal (i.e. percentage of target ultrafiltration achieved)calculated as the actual ultrafiltration volume divided by the target (ordered) ultrafiltration volume).
Time frame: Through study completion, on average 1 year.
New or increased vasopressor use during SLED sessions
Initiation or any increase in vasopressor dose(s) before the completion of a SLED session relative to the start.
Time frame: Through study completion, on average 1 year.
Change in mean arterial blood pressure (MAP) < 55 mmHg during SLED sessions
Percentage of SLED sessions during which patients' MAP (defined as \[(2X diastolic blood pressure) + systolic blood pressure\]/3) falls to \<55 mmHg at any time during the SLED session.
Time frame: Through study completion, on average 1 year.
Change in MAP of >=20 mmHg during the SLED sessions.
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Percentage of SLED sessions during which patients' MAP falls by \>=20 mmHg relative to their MAP at the start of the SLED session.
Time frame: Through study completion, on average 1 year.