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

NCT02055872 | Completed Phase 3 Results

• 1 other identifier: NIF-13343
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Edema; Hypoproteinemia; Albumin; Diuresis; Critical illness

Outcome Measures

Primary Outcomes (1)

• Ventilator-free Days

  Ventilator-free days

  30 days

Secondary Outcomes (7)

• Serum Albumin and Colloid Osmotic Pressure

  Day 1, Day 3, Day 5

• Mortality

  30 days

• Fluid Balance and Body Weight

  Day 1, Day 3, Day 5

• Oxygenation

  Day 1, Day 3, Day 5

• Treatment Interruptions

  Day 1, Day 2, Day 3

Other Outcomes (4)

• Adherence to Protocol

  Day 1

• Completion of Study Treatment

  Day 3

• Absence of Co-intervention

  Day 3

Study Arms (2)

Intravenous albumin

EXPERIMENTAL

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

Drug: Intravenous albumin

Normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Intravenous albumin DRUG

Intravenous albumin

Normal saline DRUG

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

• 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.

  PMID: 24919684 DERIVED

MeSH Terms

Conditions

Edema; Hypoproteinemia; Critical Illness

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Simon Oczkowski
• Organization: McMaster University

oczkowsj@mcmaster.ca

905 521 2100

Study Officials

• Simon Oczkowski, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 25, 2024
• Results First Posted: March 25, 2024

Record last verified: 2023-09

Locations

CA (1)