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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
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
Objective: The primary aim of this 30 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.

Condition or disease Intervention/treatment Phase
Renal Replacement Therapy Acute Kidney Injury Hypotension Biological: 25% Albumin fluid Other: Normal Saline Phase 2

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: 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 24 months ]
    Percentage of eligible patients that are successfully recruited into the study


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Edward G Clark, MD, MSc 613-738-8400 ext x82569 edclark@toh.ca
Contact: Irene Watpool, RN, BScN 613-737-8724 iwatpool@toh.ca

Locations
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Canada, Ont
The Ottawa Hospital Recruiting
Ottawa, Ont, Canada, K2G 2H1
Contact: Irene Watpool, RN BScN    613-737-8724 ext 78724    iwatpool@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Edward G Clark, MD, MSc The Ottawa Hospital Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03665311     History of Changes
Other Study ID Numbers: CRRF 316
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:
Albumin
Normal Saline
Dialysis
Intensive Care Unit

Additional relevant MeSH terms:
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Acute Kidney Injury
Hypotension
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases