Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
Acute heart failure is a condition where the heart suddenly cannot pump blood well enough for the body's needs. Many people admitted to the hospital with acute heart failure have too much fluid in the body. This can cause shortness of breath, swelling, and the need for treatment with water-removing medicine.
Furosemide is a commonly used water-removing medicine that is given into a vein to treat fluid overload. It can be given in different ways. One way is as a continuous infusion, where the medicine is given slowly over time through a pump. Another way is as repeated injections given several times a day. It is not known whether one of these ways is better than the other for removing excess fluid in people with acute heart failure.
The purpose of this study is to compare two ways of giving furosemide into a vein: Continuous infusion started with an initial extra dose, and bolus injections given three times a day. About 436 adults admitted to hospitals in Denmark with acute heart failure and fluid overload will take part. Participants will be randomly assigned to one of the two treatment groups. This means that chance will decide which treatment method each participant receives.
The main thing the researchers will measure is how much body weight participants lose about 3 days after randomization. Weight loss is used as a measure of how much excess fluid has been removed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of acute heart failure with volume overload
At least 1 sign of volume overload
Anticipated intravenous furosemide treatment for at least 3 days
Age 18 years or older
Disqualifiers
Shock
Patient requiring treatment with inotropes or vasopressors
Current or planned use of renal replacement therapy or ultrafiltration
Patient with a renal transplant
Trial design
Design model
Parallel
Treatments tested in this trial
Intravenous furosemide continuous infusion
DrugIntravenous furosemide administered as a continuous infusion preceded by a loading dose. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
Intravenous furosemide bolus injections
DrugIntravenous furosemide administered as bolus injections three times a day. The first bolus injection includes an additional dose to mirror the loading dose strategy used in the continuous infusion group. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
Treatment groups
436 Participants
are divided into 2 treatment groupsGroup A: Continuous infusion preceded by a loading doseExperimental treatment 1 intervention
Group B: Bolus injections three times a dayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Net weight loss 3 days after randomization
Net change in body weight from randomization to the morning of Day 4, corresponding to approximately 72 hours after randomization.
Time frame
From randomization to approximately 72 hoursSecondary outcomes
1
Net weight loss 2 days after randomization
Net change in body weight from randomization to the morning of Day 3, corresponding to approximately 48 hours after randomization.
Time frame
From randomization to approximately 48 hours2
Change in dyspnea 3 days after randomization
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 4, corresponding to approximately 72 hours after randomization.
Time frame
From randomization to approximately 72 hours3
Days alive out of hospital to Day 30
Number of days alive and out of hospital from randomization to Day 30.
Time frame
From randomization to 30 days4
Length of hospital stay
Duration of the index hospital admission.
Time frame
From randomization up to 30 daysOther outcomes
1
Net weight loss 1 day after randomization
Net change in body weight from randomization to the morning of Day 2, corresponding to approximately 24 hours after randomization.
Time frame
From randomization to approximately 24 hours2
Change in dyspnea 1 day after randomization
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 2, corresponding to approximately 24 hours after randomization.
Time frame
From randomization to approximately 24 hours3
Change in dyspnea 2 days after randomization
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 3, corresponding to approximately 48 hours after randomization.
Time frame
From randomization to approximately 48 hours4
Death from any cause after 30 days
All-cause mortality assessed 30 days after randomization.
Time frame
From randomization to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Central Denmark Region
Collaborator
Source ClinicalTrials.gov