EdemaPhase 3FADENCT02055872
Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial
A Phase 3 study testing Intravenous albumin and Normal saline in people with Edema and Hypoproteinemia, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema, Hypoproteinemia
- What is being tested?
- Intravenous albumin and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Oct 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Edema, Hypoproteinemia
- Being tested
- Intravenous albumin, Normal saline
- Keywords
- Edema, Hypoproteinemia, Albumin, Diuresis, Critical illness
- Medical subject headings
- Edema, Hypoproteinemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous albuminDrug
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous albumin | Experimental | Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) Receives: Drug: Intravenous albumin |
| Normal saline | Placebo comparator | Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments) Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free Days
Ventilator-free days
Measured: 30 days
Secondary outcomes (7)
Serum Albumin and Colloid Osmotic Pressure
Changes in serum albumin and serum colloid osmotic pressure measurements from Day 1, Day 3, Day 5
Measured: Day 1, Day 3, Day 5
Mortality
Total ICU mortality and mortality at 30 days.
Measured: 30 days
Fluid Balance and Body Weight
Change in total fluid balance and body weight from baseline at 3 days and 5 days
Measured: Day 1, Day 3, Day 5
Oxygenation
Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5
Measured: Day 1, Day 3, Day 5
Treatment Interruptions
Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.)
Measured: Day 1, Day 2, Day 3
Duration of Mechanical Ventilation
Total duration of mechanical ventilation
Measured: 30 days
Length of ICU Stay
Measured: Study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Oczkowski, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055872
- Sponsor's protocol ID
- NIF-13343
- Acronym
- FADE
- Status last verified
- Sep 2023
- First submitted
- 4 Feb 2014
- Last updated
- 25 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24919684
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02055872
- Acronym / sponsor ID
- FADE / NIF-13343
- Conditions
- Edema, Hypoproteinemia
- Keywords
- Edema, Hypoproteinemia, Albumin, Diuresis, Critical illness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Posted 25 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous albumin | Experimental | Drug: Intravenous albuminAdministration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) |
| Normal saline | Placebo comparator | Drug: Normal salineAdministration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous albumin | Drug | Intravenous albumin |
| Normal saline | Drug | Normal saline |
Primary outcome
Ventilator-free Days
Time frame: 30 days
Ventilator-free days
7 secondary outcomes
Serum Albumin and Colloid Osmotic Pressure
Time frame: Day 1, Day 3, Day 5
Mortality
Time frame: 30 days
Fluid Balance and Body Weight
Time frame: Day 1, Day 3, Day 5
Oxygenation
Time frame: Day 1, Day 3, Day 5
Treatment Interruptions
Time frame: Day 1, Day 2, Day 3
Duration of Mechanical Ventilation
Time frame: 30 days
Length of ICU Stay
Time frame: Study end
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24919684Oczkowski 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.
Related trials for Edema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Oczkowski, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous albumin and Normal saline in people with Edema and Hypoproteinemia, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free Days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02055872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.