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

Phase 2

Completed

• Conditions: Acute Kidney Injury; Hypotension; Renal Replacement Therapy
• Interventions: Other: Normal Saline; Biological: 25% Albumin fluid

• Registration Number: NCT03665311
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Study Start: 2019-03-25
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. age ≥ 18 yrs;
2. AKI treated with SLED (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines48).

Exclusion Criteria

1. SLED initiated for non AKI-related indication (i.e. concurrent intoxication; treatment of hypothermia);
2. receiving chronic dialysis treatments;
3. history of allergic reaction to albumin;
4. pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	100 mL 0.9% Normal Saline at the initiation of SLED and another 100 mL 0.9% Normal Saline after 4 hours of treatment
25% Albumin fluid	25% Albumin fluid	100 mL 25% Albumin fluid at the initiation of SLED and another 100 mL 25% Albumin fluid after 4 hours of treatment

Primary Outcome Measures

Name	Time	Method
Recruitment rate	24 months	Percentage of eligible patients that are successfully recruited into the study

Secondary Outcome Measures

Name	Time	Method
Change in mean arterial blood pressure (MAP) < 55 mmHg during SLED sessions	Through study completion, on average 1 year.	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.
Completeness of follow-up	24 months	Percentage of patients who have complete data available with respect to the primary and other secondary outcomes at the end of the study.
Volume removal achieved during SLED sessions	Through study completion, on average 1 year.	Overall fluid removal (i.e. percentage of target ultrafiltration achieved)calculated as the actual ultrafiltration volume divided by the target (ordered) ultrafiltration volume).
New or increased vasopressor use during SLED sessions	Through study completion, on average 1 year.	Initiation or any increase in vasopressor dose(s) before the completion of a SLED session relative to the start.
Adherence to intervention	Through study completion, on average 1 year.	Percentage of SLED sessions in which patients received their allocated intervention (or placebo).
Change in MAP of >=20 mmHg during the SLED sessions.	Through study completion, on average 1 year.	Percentage of SLED sessions during which patients' MAP falls by \>=20 mmHg relative to their MAP at the start of the SLED session.

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ont, Canada