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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous albumin | Experimental | Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) |
|
| Normal saline | Placebo Comparator | Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous albumin | Drug |
| ||
| Normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free Days | Ventilator-free days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Albumin and Colloid Osmotic Pressure | Changes in serum albumin and serum colloid osmotic pressure measurements from Day 1, Day 3, Day 5 | Day 1, Day 3, Day 5 |
| Mortality | Total ICU mortality and mortality at 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Protocol | The administration of at least the first dose of study treatment (albumin or placebo) within two hours of the first administration of furosemide | Day 1 |
| Completion of Study Treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Oczkowski, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24919684 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Albumin (n=24) | Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) Intravenous albumin |
| FG001 | Normal Saline (n=21) | Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments) Normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Albumin (n=24) | Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) Intravenous albumin |
| BG001 | Normal Saline (n=21) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ventilator-free Days | Ventilator-free days | Posted | Median | Inter-Quartile Range | days | 30 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Albumin (n=24) | Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) Intravenous albumin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon Oczkowski | McMaster University | 905 521 2100 | 42442 | oczkowsj@mcmaster.ca |
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| ID | Term |
|---|---|
| D004487 | Edema |
| D007019 | Hypoproteinemia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| 30 days |
| Fluid Balance and Body Weight | Change in total fluid balance and body weight from baseline at 3 days and 5 days | Day 1, Day 3, Day 5 |
| Oxygenation | Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5 | Day 1, Day 3, Day 5 |
| Treatment Interruptions | Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.) | Day 1, Day 2, Day 3 |
| Duration of Mechanical Ventilation | Total duration of mechanical ventilation | 30 days |
| Length of ICU Stay | Study end |
Patients receiving full 72 hours (6 doses) of study treatment
| Day 3 |
| Absence of Co-intervention | Absence of hyperoncotic albumin administration to patients randomized to the control arm | Day 3 |
| Randomization Rate |
| Study duration |
Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments)
Normal saline
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Serum Albumin and Colloid Osmotic Pressure | Changes in serum albumin and serum colloid osmotic pressure measurements from Day 1, Day 3, Day 5 | Not Posted | Day 1, Day 3, Day 5 | Participants |
| Secondary | Mortality | Total ICU mortality and mortality at 30 days. | Not Posted | 30 days | Participants |
| Secondary | Fluid Balance and Body Weight | Change in total fluid balance and body weight from baseline at 3 days and 5 days | Not Posted | Day 1, Day 3, Day 5 | Participants |
| Secondary | Oxygenation | Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5 | Not Posted | Day 1, Day 3, Day 5 | Participants |
| Secondary | Treatment Interruptions | Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.) | Not Posted | Day 1, Day 2, Day 3 | Participants |
| Secondary | Duration of Mechanical Ventilation | Total duration of mechanical ventilation | Not Posted | 30 days | Participants |
| Secondary | Length of ICU Stay | Not Posted | Study end | Participants |
| Other Pre-specified | Adherence to Protocol | The administration of at least the first dose of study treatment (albumin or placebo) within two hours of the first administration of furosemide | Not Posted | Day 1 | Participants |
| Other Pre-specified | Completion of Study Treatment | Patients receiving full 72 hours (6 doses) of study treatment | Not Posted | Day 3 | Participants |
| Other Pre-specified | Absence of Co-intervention | Absence of hyperoncotic albumin administration to patients randomized to the control arm | Not Posted | Day 3 | Participants |
| Other Pre-specified | Randomization Rate |
| Not Posted | Study duration | Participants |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Normal Saline (n=21) | Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments) Normal saline | 0 | 21 | 4 | 21 |
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| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |