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

Edema Clinical Trial

— FADE  

Official title:

A Single-centre, Randomized, Double-blinded, Placebo-controlled Pilot Study to Determine the Feasibility of a Full-scale Clinical Trial to Compare the Effect of Furosemide With or Without 25% Albumin in the Diuresis of Edema in Volume-overloaded ICU Patients in the Post-resuscitation Phase of Illness.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055872
• Other study ID #: NIF-13343
• Status: Completed
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: October 2016

Study information

• Verified date: September 2023
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Hypoproteinemia

Intervention

Drug:
• Intravenous albumin

• Normal saline

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Completion of Study Treatment	Patients receiving full 72 hours (6 doses) of study treatment	Day 3
Other	Absence of Co-intervention	Absence of hyperoncotic albumin administration to patients randomized to the control arm	Day 3
Other	Randomization Rate	Randomization rate of patients eligible by screening criteria; Randomization rate of patients eligible by clinical site	Study duration
Primary	Ventilator-free Days	Ventilator-free days	30 days
Secondary	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
Secondary	Mortality	Total ICU mortality and mortality at 30 days.	30 days
Secondary	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
Secondary	Oxygenation	Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5	Day 1, Day 3, Day 5
Secondary	Treatment Interruptions	Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.)	Day 1, Day 2, Day 3
Secondary	Duration of Mechanical Ventilation	Total duration of mechanical ventilation	30 days
Secondary	Length of ICU Stay		Study end