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

Acute Kidney Injury Clinical Trial

— SAFER-SLED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665311
• Other study ID #: CRRF 316
• Status: Completed
• Phase: Phase 2
• Start date: March 25, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: June 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hypotension
• Renal Replacement Therapy

Intervention

Biological:
• 25% Albumin fluid
25% Albumin fluid (100 mL)

Other:
• Normal Saline
0.9% Normal Saline (100 mL)

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ont

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Percentage of eligible patients that are successfully recruited into the study	24 months
Secondary	Adherence to intervention	Percentage of SLED sessions in which patients received their allocated intervention (or placebo).	Through study completion, on average 1 year.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.