Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial (FADE)

Hamilton Health Sciences (HHS)

Status and phase: Completed; Phase 3

Conditions: Edema; Hypoproteinemia

Treatments: Drug: Normal saline; Drug: Intravenous albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT02055872

NIF-13343

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Intravenous albumin

Experimental group

Description:

Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments)

Treatment:

Drug: Intravenous albumin

Normal saline

Placebo Comparator group

Description:

Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments)

Treatment:

Drug: Normal saline