Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis Feasibility Study (SAFER-SLED)
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|ClinicalTrials.gov Identifier: NCT03665311|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Renal Replacement Therapy Acute Kidney Injury Hypotension||Biological: 25% Albumin fluid Other: Normal Saline||Phase 2|
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: 30 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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized controlled trial with two parallel arms 1:1|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The packaging for normal saline and 25% albumin will be identical (glass bottles) and be covered. The intravenous tubing will have an opaque sleeve to mask any colour discrepancy in the 2 products|
|Official Title:||Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis (SAFER-SLED): A Feasibility Study|
|Actual Study Start Date :||March 25, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
Placebo Comparator: Normal Saline
100 mL 9% Normal Saline at the initiation of SLED and another 100 mL 9% Normal Saline after 4 hours of treatment
Other: Normal Saline
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)
- Recruitment rate [ Time Frame: 24 months ]Percentage of eligible patients that are successfully recruited into the study
- Adherence to intervention [ Time Frame: Through study completion, on average 1 year. ]Percentage of SLED sessions in which patients received their allocated intervention (or placebo).
- Completeness of follow-up [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Change in mean arterial blood pressure (MAP) < 55 mmHg during SLED sessions [ Time Frame: 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.
- Change in MAP of >=20 mmHg during the SLED sessions. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665311
|Contact: Edward G Clark, MD, MSc||613-738-8400 ext email@example.com|
|Contact: Irene Watpool, RN, BScNfirstname.lastname@example.org|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ont, Canada, K2G 2H1|
|Contact: Irene Watpool, RN BScN 613-737-8724 ext 78724 email@example.com|
|Principal Investigator:||Edward G Clark, MD, MSc||The Ottawa Hospital Research Institute|