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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Hypotension; Renal Replacement Therapy
• Intervention / Treatment: Other: Normal Saline; Biological: 25% Albumin fluid

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ont
    • Ottawa, Ont, Canada, K2G 2H1
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Other: Normal Saline; 0.9% Normal Saline (100 mL)
Active Comparator: 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	Biological: 25% Albumin fluid; 25% Albumin fluid (100 mL)

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Edward G Clark, MD, MSc, The Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• Clark EG, McIntyre L, Watpool I, Kong JWY, Ramsay T, Sabri E, Canney M, Hundemer GL, Brown PA, Sood MM, Hiremath S. Intravenous albumin for the prevention of hemodynamic instability during sustained low-efficiency dialysis: a randomized controlled feasibility trial (The SAFER-SLED Study). Ann Intensive Care. 2021 Dec 13;11(1):174. doi: 10.1186/s13613-021-00962-x.
• Clark EG, McIntyre L, Ramsay T, Tinmouth A, Knoll G, Brown PA, Watpool I, Porteous R, Montroy K, Harris S, Kong J, Hiremath S. Saline versus albumin fluid for extracorporeal removal with slow low-efficiency dialysis (SAFER-SLED): study protocol for a pilot trial. Pilot Feasibility Stud. 2019 May 30;5:72. doi: 10.1186/s40814-019-0460-3. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Dialysis; Albumin; Normal Saline
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Hypotension
• Other Study ID Numbers: CRRF 316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No