Phase 3
N=45
Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial
Edema · Hypoproteinemia
Bottom Line
View on ClinicalTrials.gov: NCT02055872 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Ventilator-free Days — 4; 13 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intravenous albumin (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hamilton Health Sciences Corporation
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ventilator-free Days |
4; 13 | — |
| SECONDARY Serum Albumin and Colloid Osmotic Pressure |
— | — |
| SECONDARY Mortality |
— | — |
| SECONDARY Fluid Balance and Body Weight |
— | — |
| SECONDARY Oxygenation |
— | — |
| SECONDARY Treatment Interruptions |
— | — |
| SECONDARY Duration of Mechanical Ventilation |
— | — |
| SECONDARY Length of ICU Stay |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02055872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.