Back to resultsFurosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial (FADE)
Primary Purpose
Edema, Hypoproteinemia
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Intravenous albumin
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Edema focused on measuring Edema, Hypoproteinemia, Albumin, Diuresis, Critical illness
Eligibility Criteria
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
Sites / Locations
- Hamilton Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intravenous albumin
Normal saline
Arm Description
Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments)
Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments)
Outcomes
Primary Outcome Measures
Ventilator-free days
Ventilator-free days
Secondary Outcome Measures
Serum albumin and colloid osmotic pressure
Changes in serum albumin and serum colloid osmotic pressure measurements from Day 1, Day 3, Day 5
Mortality
Total ICU mortality and mortality at 30 days.
Fluid balance and body weight
Change in total fluid balance and body weight from baseline at 3 days and 5 days
Oxygenation
Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5
Treatment interruptions
Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.)
Duration of Mechanical Ventilation
Total duration of mechanical ventilation
Length of ICU Stay
Full Information
NCT ID
NCT02055872
First Posted
February 4, 2014
Last Updated
October 7, 2016
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02055872
Brief Title
Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial
Acronym
FADE
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema, Hypoproteinemia
Keywords
Edema, Hypoproteinemia, Albumin, Diuresis, Critical illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous albumin
Arm Type
Experimental
Arm Description
Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments)
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments)
Intervention Type
Drug
Intervention Name(s)
Intravenous albumin
Intervention Type
Drug
Intervention Name(s)
Normal saline
Primary Outcome Measure Information:
Title
Ventilator-free days
Description
Ventilator-free days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Serum albumin and colloid osmotic pressure
Description
Changes in serum albumin and serum colloid osmotic pressure measurements from Day 1, Day 3, Day 5
Time Frame
Day 1, Day 3, Day 5
Title
Mortality
Description
Total ICU mortality and mortality at 30 days.
Time Frame
30 days
Title
Fluid balance and body weight
Description
Change in total fluid balance and body weight from baseline at 3 days and 5 days
Time Frame
Day 1, Day 3, Day 5
Title
Oxygenation
Description
Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5
Time Frame
Day 1, Day 3, Day 5
Title
Treatment interruptions
Description
Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.)
Time Frame
Day 1, Day 2, Day 3
Title
Duration of Mechanical Ventilation
Description
Total duration of mechanical ventilation
Time Frame
30 days
Title
Length of ICU Stay
Time Frame
Study end
Other Pre-specified Outcome Measures:
Title
Adherence to Protocol
Description
The administration of at least the first dose of study treatment (albumin or placebo) within two hours of the first administration of furosemide
Time Frame
Day 1
Title
Completion of study treatment
Description
Patients receiving full 72 hours (6 doses) of study treatment
Time Frame
Day 3
Title
Absence of co-intervention
Description
Absence of hyperoncotic albumin administration to patients randomized to the control arm
Time Frame
Day 3
Title
Randomization rate
Description
Randomization rate of patients eligible by screening criteria
Randomization rate of patients eligible by clinical site
Time Frame
Study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Oczkowski, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24919684
Citation
Oczkowski SJ, Mazzetti I, Meade MO, Hamielec C. Furosemide and albumin for diuresis of edema (FADE): a study protocol for a randomized controlled trial. Trials. 2014 Jun 12;15:222. doi: 10.1186/1745-6215-15-222.
Results Reference
derived
Learn more about this trial
Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial
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