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Furosemide Ph. Eur.

This article discusses a clinical trial investigating the use of Furosemide Ph. Eur., a loop diuretic, for goal-directed fluid removal in critically ill patients with fluid overload. The study, known as the GODIF trial, aims to assess the benefits and potential risks of using Furosemide compared to a placebo in adult ICU patients with moderate to severe fluid accumulation.

Table of Contents

What is Furosemide?

Furosemide (also known as FUROSEMIDE PH. EUR.) is a medication that belongs to a class of drugs called loop diuretics.[1] Loop diuretics are medications that help your body get rid of excess fluid by increasing urine production. Furosemide is commonly used in medical settings, particularly in intensive care units (ICUs), to treat patients with fluid overload.

Medical Conditions Treated by Furosemide

Furosemide is primarily used to treat fluid overload or fluid accumulation.[1] Fluid overload is a condition where there is too much fluid in the body, which can lead to swelling, breathing difficulties, and other health problems. This condition can occur in various situations, including:

  • Heart failure
  • Kidney problems
  • Liver disease
  • Certain lung conditions
  • After major surgery
  • In critically ill patients in the ICU

How Furosemide Works

Furosemide works by helping your kidneys remove excess fluid from your body. It does this by:

  1. Increasing urine production
  2. Promoting the excretion of salt (sodium and chloride) and water
  3. Reducing fluid buildup in tissues, which can help decrease swelling

By removing excess fluid, furosemide can help improve symptoms associated with fluid overload, such as shortness of breath and swelling in the legs and ankles.

How Furosemide is Administered

In the clinical trial described, furosemide is administered through intravenous infusion.[1] This means the medication is given directly into a vein through a small tube called an IV. Intravenous administration allows the medication to work quickly and is often used in hospital settings, especially for patients in the ICU.

Dosage Information

The dosage of furosemide can vary depending on the individual patient’s needs and condition. In the clinical trial mentioned, the following dosage information is provided:[1]

  • Maximum daily dose: 1500 mg
  • Maximum total dose: 135,000 mg
  • Maximum treatment period: 3 months

It’s important to note that these doses are specific to the clinical trial and may not reflect typical dosing in other medical situations. Always follow your healthcare provider’s instructions regarding medication dosage.

Current Clinical Trial: GODIF

A clinical trial called GODIF (Goal Directed Fluid Removal) is currently being conducted to study the effects of furosemide in critically ill patients with fluid overload.[1] The main objective of this trial is to determine if using furosemide to remove excess fluid can improve patient outcomes compared to allowing the body to remove fluid naturally (placebo group).

Eligibility Criteria for the GODIF Trial

To participate in the GODIF trial, patients must meet specific criteria. These include:[1]

  • Acute admission to the ICU
  • 18 years of age or older
  • Clinically stable condition (as assessed by doctors)
  • Fluid accumulation of at least 5% of ideal body weight

There are also several conditions that would exclude a patient from participating in the trial, such as known allergy to furosemide, severe kidney or liver problems, and certain other medical conditions.

Potential Benefits and Outcomes

The GODIF trial aims to assess several important outcomes for patients treated with furosemide, including:[1]

  • Number of days alive and out of the hospital at 90 days after treatment
  • Overall survival rate at 90 days and 1 year
  • Days alive without needing life support
  • Quality of life after 1 year
  • Cognitive function after 1 year

These outcomes will help researchers understand the potential benefits and risks of using furosemide for fluid removal in critically ill patients with fluid overload.

Aspect Details
Trial Name GODIF (Goal directed fluid removal in critically ill patients with fluid overload)
Drug Studied Furosemide Ph. Eur. (loop diuretic)
Main Objective Assess benefits and harms of goal-directed fluid removal with Furosemide vs. placebo in ICU patients with fluid overload
Primary Endpoint Number of days alive and out of hospital at day 90
Key Inclusion Criteria Adult ICU patients with fluid accumulation ≥5% of ideal body weight
Key Exclusion Criteria Allergy to Furosemide, advanced kidney disease, ongoing renal replacement therapy
Drug Administration Intravenous infusion, max daily dose 1500 mg, max total dose 135,000 mg
Treatment Duration Up to 3 months

FAQ

  • What is the main goal of the GODIF trial? The main goal of the GODIF trial is to determine if forced fluid removal using Furosemide is more effective than placebo (spontaneous fluid excretion) in increasing the number of days alive and out of hospital at day 90 for adult ICU patients with moderate to severe fluid overload.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 years or older) admitted to the ICU with fluid accumulation of at least 5% of ideal body weight. They must be clinically stable with specific criteria for blood pressure, noradrenaline infusion, and lactate levels.
  • What are some reasons a person might be excluded from the trial? Exclusion criteria include known allergy to Furosemide or sulfonamides, advanced chronic kidney disease, ongoing renal replacement therapy, anuria for 6 hours or more, severe liver failure, and pregnancy, among others.
  • What outcomes will the researchers measure in this study? The primary outcome is the number of days alive and out of hospital at day 90. Secondary outcomes include all-cause mortality at 90 days and 1 year, days alive without life support, serious adverse events, health-related quality of life, and cognitive function after 1 year.
  • How is Furosemide administered in this trial? Furosemide is administered through intravenous infusion. The maximum daily dose is 1500 mg, with a maximum total dose of 135,000 mg over a maximum treatment period of 3 months.

Ongoing Clinical Trials on Furosemide Ph. Eur.

  • Study on Fluid Removal Using Furosemide and Amiloride Hydrochloride in ICU Patients with Fluid Overload

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Lithuania The Netherlands Sweden

Glossary

  • Furosemide Ph. Eur.: A loop diuretic medication used to remove excess fluid from the body. In this trial, it's being studied for its effectiveness in treating fluid overload in critically ill patients.
  • ICU: Intensive Care Unit, a special department in hospitals that provides intensive care and treatment to critically ill patients.
  • Fluid overload: A condition where there is too much fluid in the body, which can cause swelling and other health problems.
  • Placebo: A substance with no active medical effects, used as a control in testing new drugs. In this study, a saline solution (NaCl 0.9%) is used as the placebo.
  • Anuria: A condition where the kidneys do not produce urine, or produce very little urine.
  • Renal replacement therapy: A treatment that replaces the normal blood-filtering function of the kidneys, such as dialysis.
  • Dysnatraemia: An imbalance of sodium levels in the blood, which can be either too high or too low.
  • Rhabdomyolysis: A serious condition resulting from the breakdown of damaged muscle tissue.
  • EQ-5D-5L and EQ-VAS: Standardized tools used to measure health-related quality of life.
  • Montreal Cognitive Assessment test (MoCA): A test used to evaluate cognitive function, including memory, attention, and problem-solving skills.

References

  1. http://clinicaltrials.eu/trial/study-on-fluid-removal-using-furosemide-and-amiloride-hydrochloride-in-icu-patients-with-fluid-overload/