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

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients experiencing fluid overload, a condition where there is too much fluid in the body, often seen in critically ill patients in intensive care units (ICU). The treatment being tested is furosemide, a medication that helps remove excess fluid from the body. The study will compare the effects of furosemide with a placebo, which is a substance with no active medication, to see if furosemide can help patients recover more quickly and spend more days alive and out of the hospital within 90 days.

The purpose of the study is to determine whether using furosemide for fluid removal is more beneficial than allowing the body to remove fluid on its own. Participants in the study will receive either furosemide or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the number of days patients are alive and out of the hospital, as well as other important health outcomes, over a period of 90 days and up to one year.

Throughout the study, researchers will also look at other factors such as overall survival rates, the number of days patients can live without needing life support, and any serious side effects. Additionally, the study will assess the quality of life and cognitive function of participants after one year. This research aims to provide valuable insights into the management of fluid overload in ICU patients and improve treatment strategies for this condition.

1 joining the study

Upon joining the study, the patient is confirmed to meet the inclusion criteria. This includes being 18 years or older, having an acute admission to the intensive care unit (ICU), and being clinically stable. Fluid accumulation must be at least 5% of the ideal body weight.

2 randomization

The patient is randomly assigned to receive either the active medication, furosemide, or a placebo. The placebo is a sodium chloride 0.9% solution for intravenous infusion.

3 medication administration

The assigned medication, either furosemide or placebo, is administered through an intravenous infusion. The dosage and frequency are determined by the study protocol, focusing on goal-directed fluid removal.

4 monitoring and assessment

Throughout the trial, the patient’s fluid balance, body weight, and clinical stability are closely monitored. The primary goal is to assess the number of days the patient is alive and out of the hospital by day 90.

5 follow-up evaluations

At day 90, secondary outcomes such as all-cause mortality, days alive without life support, and any serious adverse events are evaluated. Further assessments include health-related quality of life and cognitive function at one year.

6 completion of the trial

The trial is estimated to conclude by February 29, 2028. Final evaluations include long-term outcomes such as one-year mortality and quality of life assessments.

Who Can Join the Study?

The patient must be admitted to the Intensive Care Unit (ICU) for an urgent or emergency reason.
The patient must be 18 years old or older.
The patient must be considered clinically stable by the doctors. This means:
- The patient’s Mean Arterial Pressure (MAP) should be more than 50 mmHg. MAP is a measure of the average blood pressure in a person’s arteries during one cardiac cycle.
- The patient should not be receiving more than 20 micrograms per kilogram per minute of noradrenaline. Noradrenaline is a medication used to increase blood pressure.
- The patient’s lactate level should be less than 4.0 mmol/l. Lactate is a substance that can build up in the body when cells do not get enough oxygen.
The patient must have fluid accumulation that is estimated to be at least 5% of their ideal body weight. This is determined by:
- Daily fluid balance, which is the difference between fluid intake and fluid output.
- Cumulative fluid balance, which is the total fluid balance over a period of time.
- Changes in body weight.
- Clinical examination by a healthcare professional.
Both male and female patients can participate.
The study does not include vulnerable populations, which means groups that might need special protection or care.

Who Cannot Join the Study?

Patients who do not have fluid overload. This means they do not have too much fluid in their body.
Patients who are not in the ICU. The ICU is the Intensive Care Unit, a special part of the hospital for very sick patients.
Patients who are not adults. This means they are younger than 18 years old.
Patients who are part of a vulnerable population. This means they are in a group that needs special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Fakultni Nemocnice Plzen	Plzen	Czechia
Odense University Hospital	Odense	Denmark
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Gentofte Hospital	Hellerup	Denmark
Roskilde University	Roskilde	Denmark
Region Sjaelland	Holbæk	Denmark
University Hospital Ostrava	Ostrava	Czechia
Regionshospital Nordjylland	Hjørring	Denmark
Soedersjukhuset AB	Stockholm	Sweden
Ibbvvjcln Fre Cdonwupw Ath Ehendlvsvczp Mmdnjcdl	Prague	Czechia
Uyvcspihshbz Mhvhooh Cwoybjd Gahzwmczw	Groningen	The Netherlands
Hxjxgqnk Hyvopxmi	Hillerød	Denmark
Roednq Svkpzukvlc	Vejle	Denmark

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	24.08.2020
Denmark	Recruiting	24.08.2020
Lithuania	Recruiting	24.08.2020
Sweden	Not recruiting	24.08.2020
The Netherlands	Recruiting	24.08.2020

Trial locations

Investigated drugs:

Furosemide is a medication used in this trial to help remove excess fluid from the body. It is often used in intensive care settings for patients who have too much fluid in their bodies, which can happen due to various medical conditions. The goal of using furosemide in this trial is to see if it can help patients recover more quickly by increasing the number of days they are alive and out of the hospital within 90 days.

Investigated diseases:

Critical illness

Fluid Overload – Fluid overload is a condition where there is an excessive accumulation of fluid in the body, often due to an imbalance between fluid intake and excretion. This can lead to swelling, particularly in the legs and arms, and can affect the lungs, causing difficulty in breathing. It is commonly seen in patients with heart, kidney, or liver problems, where the body’s ability to manage fluid balance is compromised. The condition can progress to cause discomfort, increased blood pressure, and stress on the heart and other organs. Managing fluid overload often involves monitoring fluid intake and output to prevent further complications.

Trial ID:

2024-512186-14-00

Protocol code:

GODIF trial

NCT ID:

NCT04180397

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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