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New treatment option for Pulmonary Edema
Official title Optimized Treatment of Pulmonary Edema or Congestion
ClinicalTrials.gov ID: NCT05276219
What this study is testing
What is Furosemide Injection?
Furosemide Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pulmonary edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Intravenous (IV) loop-diuretics have been a key component in treating pulmonary edema since the nineteen sixties and has a Class 1 recommendation in the 2021 European Society of Cardiology guidelines for heart failure. Conversely, vasodilation was downgraded in the treatment of acute heart failure due to a lack of trials that compare vasodilation with loop-diuretics in a hyperacute clinical setting.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Acute (within minutes to days) onset or worsening of subjective dyspnea\
- Systolic blood pressure ≥100 mmHg
- Oxygen saturation \<94% or need of oxygen
- Signs or suspicion of congestion (peripheral edema, rales, and/or clinical suspicion of congestion) \
You likely can't join if
- More than 40 mg IV furosemide within the last three hours before randomization including prehospital treatment.
- More than 3 hours from hospital-admission to randomization
- Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \> 180 or \< 40 bpm.
- Suspected severe infection or sepsis. Exclusion criteria are purposely liberal, so patients can be included in accordance with everyday clinical...
See the full eligibility criteria
- Age ≥ 18 years
- Acute (within minutes to days) onset or worsening of subjective dyspnea\
- Systolic blood pressure ≥100 mmHg
- Oxygen saturation \<94% or need of oxygen
- Signs or suspicion of congestion (peripheral edema, rales, and/or clinical suspicion of congestion) \
- by the best assessment from a medical doctor. Inclusion must not wait on x-ray or other measures: patients suspected of pulmonary congestion should be included immediately.
- More than 40 mg IV furosemide within the last three hours before randomization including prehospital treatment.
- More than 3 hours from hospital-admission to randomization
- Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \> 180 or \< 40 bpm.
- Suspected severe infection or sepsis. Exclusion criteria are purposely liberal, so patients can be included in accordance with everyday clinical practice. However, a safety criterion will be implemented: If blood...
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Copenhagen, Denmark
- Hillerød, Denmark
- Roskilde, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Copenhagen, Denmark; Hillerød, Denmark; Roskilde, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.