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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Hamilton Health Sciences Corporation

Current Primary Outcome: Ventilator-free days [ Time Frame: 30 days ]

Ventilator-free days


Original Primary Outcome: Duration of mechanical ventilation [ Time Frame: 30 days ]

Duration of mechanical ventilation and ventilator-free days


Current Secondary Outcome:

  • Serum albumin and colloid osmotic pressure [ Time Frame: Day 1, Day 3, Day 5 ]
    Changes in serum albumin and serum colloid osmotic pressure measurements from Day 1, Day 3, Day 5
  • Mortality [ Time Frame: 30 days ]
    Total ICU mortality and mortality at 30 days.
  • Fluid balance and body weight [ Time Frame: Day 1, Day 3, Day 5 ]
    Change in total fluid balance and body weight from baseline at 3 days and 5 days
  • Oxygenation [ Time Frame: Day 1, Day 3, Day 5 ]
    Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5
  • Treatment interruptions [ Time Frame: Day 1, Day 2, Day 3 ]
    Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.)
  • Duration of Mechanical Ventilation [ Time Frame: 30 days ]
    Total duration of mechanical ventilation
  • Length of ICU Stay [ Time Frame: Study end ]


Original Secondary Outcome:

  • Serum albumin and colloid osmotic pressure [ Time Frame: Day 1, Day 3, Day 5 ]
    Changes in serum albumin and serum colloid osmotic pressure measurements from Day 1, Day 3, Day 5
  • Mortality [ Time Frame: 30 days ]
    Total ICU mortality and mortality at 30 days.
  • Fluid balance and body weight [ Time Frame: Day 1, Day 3, Day 5 ]
    Change in total fluid balance and body weight from baseline at 3 days and 5 days
  • Oxygenation [ Time Frame: Day 1, Day 3, Day 5 ]
    Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5
  • Treatment interruptions [ Time Frame: Day 1, Day 2, Day 3 ]
    Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.)


Information By: Hamilton Health Sciences Corporation

Dates:
Date Received: February 4, 2014
Date Started: September 2014
Date Completion:
Last Updated: October 7, 2016
Last Verified: October 2016