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

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 2

Conditions: Hypotension; Renal Replacement Therapy; Acute Kidney Injury

Treatments: Other: Normal Saline; Biological: 25% Albumin fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT03665311

CRRF 316

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Normal Saline

Placebo Comparator group

Description:

100 mL 0.9% Normal Saline at the initiation of SLED and another 100 mL 0.9% Normal Saline after 4 hours of treatment

Treatment:

Other: Normal Saline

25% Albumin fluid

Active Comparator group

Description:

100 mL 25% Albumin fluid at the initiation of SLED and another 100 mL 25% Albumin fluid after 4 hours of treatment

Treatment:

Biological: 25% Albumin fluid