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

NCT ID: NCT02055872

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-10-31

Brief 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.

Conditions

Edema; Hypoproteinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous albumin

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

Group Type: EXPERIMENTAL

Intravenous albumin

Intervention Type: DRUG

Normal saline

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Interventions

Intravenous albumin

Intervention Type: DRUG

Normal saline

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Oczkowski, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Hamilton Health Sciences

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 24919684 (View on PubMed)

Other Identifiers

NIF-13343

Identifier Type: -

Identifier Source: org_study_id