Condition category
Signs and Symptoms
Date applied
08/09/2013
Date assigned
20/09/2013
Last edited
13/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many intensive care unit (ICU) patients develop edema (collection of fluid in the body) due to the fluids injected through the vein used for resuscitation. Edema has been associated with longer ICU stay and higher death rate. Thus removal of fluid is important. We aim to study whether the addition of albumin, which encourages the movement of fluid from tissues back into blood vessels, can improve the effectiveness of diuretics (drugs that increase production of urine), the basis of edema treatment.

Who can participate?
Adults admitted to the intensive care unit for any reason, who have normal blood flow and low protein levels in blood, and judged to be in need of diuresis (increased production of urine).

What does the study involve?
Participants will be randomly allocated to receive albumin or placebo (dummy), given
two hours before the diuretic treatment. Study treatment will continue for 72 hours, or less if the doctors decide that further diuresis is unnecessary, serum albumin levels normalize, or the patient leaves the ICU. Study treatment will also be held if the doctors are withholding the diuretic treatment. If diuresis is resumed, the patient will restart their assigned treatment (albumin or placebo). 

What are the possible benefits and risks of participating?
Patients will receive access to a potentially beneficial strategy of diuresis involving the use of
albumin in addition to the usual care. There are no known cases of transmission of germs from receiving albumin despite decades of use, and the overall risk is therefore extremely remote. Some study tests will require one extra tube of blood to be collected; all other data collection and treatment is as per routine ICU care and poses no extra risk. 

Where is the study run from?
This study will be conducted at intensive care units of Juravinski Hospital and Hamilton General Hospital, Hamilton, Ontario, Canada.

When is study starting and how long is it expected to run for?
Recruitment is anticipated to begin early 2014, and continue for 6-7 months, or until 50 patients are recruited.

Who is funding the study?
Hamilton Health Sciences, Canada.

Who is the main contact?
Dr Simon Oczkowski
simon.oczkowski@medportal.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cindy Hamielec

ORCID ID

Contact details

Hamilton Health Sciences
General Site
237 Barton Street E 
Hamilton
L8L 2X2
Canada
hamiecin@hhsc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02055872

Protocol/serial number

N/A

Study information

Scientific title

Hyperoncotic albumin to improve diuresis in critically ill patients: a pilot randomized controlled trial

Acronym

FADE

Study hypothesis

We hypothesize that hyperoncotic albumin, given prior to diuretics, in edematous critically ill patients with hypoproteinemia, will improve diuresis, oxygenation, and hemodynamics. This trial is a pilot RCT to assess the feasibility of such a trial.

On 17/04/2014 the anticipated start date was changed from 01/01/2014 to 04/03/2014.

Ethics approval

Hamilton Integrated Research Ethics Board (HIREB), 04/03/2014, ref: REB #14-002

Study design

Blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Edema

Intervention

Patients are randomized to two groups:
1. 25% albumin, 100 mL intravenous twice daily
2. Placebo, during the duration of diuresis.
Patients will be followed up for 30 days or hospital discharge, which ever is sooner.

Co-investigator:
Dr. Ian Mazzetti
McMaster University
C/O Anaesthesia Department
1200 Main St. W
Hamilton Ontario
Canada
L8S 4L8

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 17/04/2014:
Our primary outcome is feasibility, including three components:
1. Adherence to protocol (administration of first dose of study treatment within 2 hours of furosemide; proportion of patients receiving all six doses of study treatment; absence of cointervention in placebo arm as documented in the medication administration record)
2. Randomization rate of eligible patients
3. Collection of study data (including blood chemistry, hemodynamic, and oxygenation data)

Previous primary outcome measures:
Our primary outcome is feasibility, including three components:
1. Adherence to protocol (administration of first 3 doses of study treatment, within 2 hours of furosemide, absence of cointervention in placebo arm, as documented in the medication administration record)
2. Randomization rate of eligible patients
3. Collection of study data (including blood chemistry, hemodynamic, and oxygenation data)

Secondary outcome measures

Current secondary outcome measures as of 17/04/2014:
Clinical outcomes will be secondary in this pilot study:
1. Ventilator-free days and duration of mechanical ventilation
2. Episodes interrupting treatment with furosemide
3. Fluid balance, oxygenation, hemodynamic status
4. Changes in serum electrolytes and albumin at day 1, 3, 5
5. Changes in colloid osmotic pressure at day 1, 3, 5
6. ICU and hospital mortality

Previous secondary outcome measures:
Clinical outcomes will be secondary in this pilot study:
1. Fluid balance, oxygenation, hemodynamic status
2. Serum chemistry data and blood gas measurements
3. Colloid osmotic pressure
4. ICU and hospital mortality

Overall trial start date

04/03/2014

Overall trial end date

01/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Intensive care unit patients, medical or surgical, of at least 18 years of age who meet the following criteria:
1. Hemodynamically stable for at least 24 hours
1.1. Absence of persistent (>1h) hypotension (systolic blood pressure < 90 mmHg) and tachycardia (heart rate >110)
1.2. Not currently on vasopressors other than low dose dopamine (less than 10 mcg/kg/min)
1.3. Less than 2L crystalloid or colloid boluses or 2 units PRBCs, maintenance fluids excluded
2. Hypoproteinemia
2.1. Serum albumin < 30 mg/L, or total protein < 60 mg/L
3. Clinical decision to diurese at least 3L net fluid balance within the next 72 hours
4. For any reason, including: peripheral edema, congestive heart failure on chest x-ray, elevated CVP in the absence of right heart valvular pathology or pulmonary hypertension, elevated wedge pressure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Known pregnancy
2. Patient or surrogate unable or unwilling to consent to blood product administration, including albumin
3. History of adverse reactions or allergy to either albumin or furosemide
4. Acute kidney injury (RIFLE criteria “F” or greater - tripling of creatinine or creatinine >355 μmol/l (with a rise of >44) or average urine output below 0.3 ml/kg/hr for 24 hours) without any improvement in the past 24 hours, or otherwise expected to necessitate dialysis within 48 hours in the opinion of the treating physician
5. Chronic kidney injury requiring dialysis
6. Clinically documented cirrhosis
7. Clinically documented nephrotic syndrome
8. Serum sodium greater than 150 meq/L, or serum potassium less than 2.5 meq/L that cannot be treated prior to administration of study treatment
9. Inability to measure urine output and fluid balance
10. Receipt of hyperoncotic albumin within the preceding 24 hours
11. Previous enrollment in this RCT, or any other research studies which may interfere with this study
12. Estimated survival or ICU stay less than 72 hours.

Recruitment start date

04/03/2014

Recruitment end date

01/01/2015

Locations

Countries of recruitment

Canada

Trial participating centre

Hamilton Health Sciences, General Site
Hamilton
L8L 2X2
Canada

Sponsor information

Organisation

McMaster University Medical Centre (Canada)

Sponsor details

c/o Simon Oczkowski
Anaesthesia Department
1200 Main St. W
Hamilton
L8P2C7
Canada
simon.oczkowski@medportal.ca

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Hamilton Health Sciences - New Investigator Fund (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24919684

Publication citations

  1. Protocol

    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, 15, 222, doi: 10.1186/1745-6215-15-222.

Additional files

Editorial Notes