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NCT Number: NCT03665311

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

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Key information

Conditions

Renal Replacement Therapy Acute Kidney Injury Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypotension Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ottawa Hospital

Ottawa, Ontario, K2G 2H1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 yrs;
  • AKI treated with SLED (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines48).

Exclusion criteria

  • SLED initiated for non AKI-related indication (i.e. concurrent intoxication; treatment of hypothermia);
  • receiving chronic dialysis treatments;
  • history of allergic reaction to albumin;
  • pregnancy.

Treatment and study plan

25% Albumin fluid

Biological

25% Albumin fluid (100 mL)

Normal Saline

Other

0.9% Normal Saline (100 mL)

Primary outcomes

  1. Recruitment rate

    Time frame: 24 months

    Percentage of eligible patients that are successfully recruited into the study

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Acronym: SAFER-SLED

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2018
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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