Skip to main content
OpenTrials
Completed

NCT Number: NCT02055872

Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial

Critically ill patients usually require intravenous fluids to correct low blood pressure and improve blood flow to vital organs. However, once the patient's blood pressure has improved, these fluids can leak out into various organs, including the lung, kidneys, and skin. Excess fluid in these tissues, called edema, has been associated with longer ICU stays and higher mortality. Thus removing excess fluid is an important goal. The simplest way to treat edema is to use diuretics, such as furosemide, which increase urine output.

To further improve urine output, patients are sometimes given albumin, a protein which helps to suck fluid out from the tissues, and keep it in the blood vessel, where it can be filtered in the kidney and removed in the urine. Although albumin is often used for this purpose, there is little evidence to support it. A large randomized controlled trial is needed to determine if albumin plus furosemide is truly more effective than furosemide alone in critically ill patients with low levels of blood albumin. We will perform a pilot study to assess the feasibility of such a trial.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Edema Blood Protein Disorders Critical Illness Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hypoproteinemia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hemodynamically stable for at least 24 hours (absence of persistent [>1 h] hypotension [systolic blood pressure <90 mmHg), not currently on vasopressors, less than 2 L crystalloid or colloid boluses, or 2 units red blood cells administered, maintenance fluids excluded
  • Hypoproteinemia (serum albumin <30 mg/L or total protein < 60 mg/L)
  • Clinical decision to diurese at least 3 L net fluid balance within the next 72 hours for any reason

Exclusion criteria

  • known pregnancy
  • patient or surrogate unable or unwilling to consent to blood product administration, including albumin
  • history of adverse reactions or allergy to either albumin or furosemide
  • acute kidney injury (RIFLE criteria "F" or greater) without any improvement in past 24 hours, or otherwise expected to necessitate dialysis within 48 hours in opinion of treating physician
  • chronic kidney injury requiring dialysis
  • clinically documented cirrhosis
  • clinically documented nephrotic syndrome
  • serum sodium greater than 150 milliequivalent/L or serum potassium less than 2.5 mEq/L that connote be treated prior to administration of study treatment
  • inability to measure urine output and fluid balance
  • Receipt of hyperoncotic albumin within preceding 24 hours
  • previous enrollment in this trial, or any research studies which may interfere with this study
  • estimated survival or ICU stay less than 72 hours

Treatment and study plan

Intravenous albumin

Drug

normal saline

Drug

Primary outcomes

  1. Ventilator-free Days

    Time frame: 30 days

    Ventilator-free days

Secondary outcomes

  1. Serum Albumin and Colloid Osmotic Pressure

    Time frame: Day 1, Day 3, Day 5

    Changes in serum albumin and serum colloid osmotic pressure measurements from Day 1, Day 3, Day 5

  2. Mortality

    Time frame: 30 days

    Total ICU mortality and mortality at 30 days.

  3. Fluid Balance and Body Weight

    Time frame: Day 1, Day 3, Day 5

    Change in total fluid balance and body weight from baseline at 3 days and 5 days

  4. Oxygenation

    Time frame: Day 1, Day 3, Day 5

    Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5

  5. Treatment Interruptions

    Time frame: Day 1, Day 2, Day 3

    Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.)

  6. Duration of Mechanical Ventilation

    Time frame: 30 days

    Total duration of mechanical ventilation

  7. Length of ICU Stay

    Time frame: Study end

Other outcomes

  1. Adherence to Protocol

    Time frame: Day 1

    The administration of at least the first dose of study treatment (albumin or placebo) within two hours of the first administration of furosemide

  2. Completion of Study Treatment

    Time frame: Day 3

    Patients receiving full 72 hours (6 doses) of study treatment

  3. Absence of Co-intervention

    Time frame: Day 3

    Absence of hyperoncotic albumin administration to patients randomized to the control arm

  4. Randomization Rate

    Time frame: Study duration

    • Randomization rate of patients eligible by screening criteria
    • Randomization rate of patients eligible by clinical site

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

A Single-centre, Randomized, Double-blinded, Placebo-controlled Pilot Study to Determine the Feasibility of a Full-scale Clinical Trial to Compare the Effect of Furosemide With or Without 25% Albumin in the Diuresis of Edema in Volume-overloaded ICU Patients in the Post-resuscitation Phase of Illness.

Acronym: FADE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2014
Registry last updated
Mar 25, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.