Clinical trial NCT02055872: Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Edema
Hypoproteinemia
Keywords: Edema
Hypoproteinemia
Albumin
Diuresis
Critical illness
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ventilator-free Days
timeFrame: 30 days
Secondary outcomes:
measure: Serum Albumin and Colloid Osmotic Pressure
timeFrame: Day 1, Day 3, Day 5
measure: Mortality
timeFrame: 30 days
measure: Fluid Balance and Body Weight
timeFrame: Day 1, Day 3, Day 5
measure: Oxygenation
timeFrame: Day 1, Day 3, Day 5
measure: Treatment Interruptions
timeFrame: Day 1, Day 2, Day 3
measure: Duration of Mechanical Ventilation
timeFrame: 30 days
measure: Length of ICU Stay
timeFrame: Study end
Other outcomes:
measure: Adherence to Protocol
timeFrame: Day 1
measure: Completion of Study Treatment
timeFrame: Day 3
measure: Absence of Co-intervention
timeFrame: Day 3
measure: Randomization Rate
timeFrame: Study duration
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Simon Oczkowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.