Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis Feasibility Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis (SAFER-SLED): A Feasibility Study

Conditions
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Renal Replacement Therapy, Acute Kidney Injury, Hypotension

Intervention / Treatment
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* Biological: 25% Albumin fluid
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 yrs; AKI treated with SLED (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines48). Exclusion Criteria: SLED initiated for non AKI-related indication (i.e. concurrent intoxication; treatment of hypothermia); receiving chronic dialysis treatments; history of allergic reaction to albumin; pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial with two parallel arms 1:1
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline<br>100 mL 0.9% Normal Saline at the initiation of SLED and another 100 mL 0.9% Normal Saline after 4 hours of treatment | Other: Normal Saline<br>* 0.9% Normal Saline (100 mL)<br>|
| Active Comparator: 25% Albumin fluid<br>100 mL 25% Albumin fluid at the initiation of SLED and another 100 mL 25% Albumin fluid after 4 hours of treatment | Biological: 25% Albumin fluid<br>* 25% Albumin fluid (100 mL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Percentage of eligible patients that are successfully recruited into the study | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to intervention | Percentage of SLED sessions in which patients received their allocated intervention (or placebo). | 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. | 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). | 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. | 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. | Through study completion, on average 1 year. | 
| Change in MAP of >=20 mmHg during the SLED sessions. | Percentage of SLED sessions during which patients' MAP falls by >=20 mmHg relative to their MAP at the start of the SLED session. | Through study completion, on average 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albumin, Normal Saline, Dialysis, Intensive Care Unit