Status:
RECRUITING
Optimized Treatment of Pulmonary Edema or Congestion
Lead Sponsor:
Johannes Grand
Collaborating Sponsors:
Zealand University Hospital
Copenhagen University Hospital, Hvidovre
Conditions:
Pulmonary Edema
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 Cardiolog...
Detailed Description
IV-loop diuretics are a central part of acute treatment of pulmonary edema and is recommended in guidelines (Class 1 recommendation) with a higher recommendation as compared to vasodilation, which was...
Eligibility Criteria
Inclusion
- Inclusion 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.
- Exclusion criteria
- 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 pressure drops below 90 mmHg in 2 measurements with 5 minutes apart and/or if urine production is below 50 ml after 1 hour, the intervention will be stopped, and patients can receive furosemide and nitrates freely.
- We purposely chose not to exclude patients with aortic stenosis, since observational studies did not find excess risk of given nitrates to patients with pulmonary edema and aortic stenosis
Exclusion
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1104 Patients enrolled
Trial Details
Trial ID
NCT05276219
Start Date
September 14 2023
End Date
December 31 2026
Last Update
December 19 2024
Active Locations (4)
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1
Bispebjerg Hospital
Copenhagen, Copenhagen, Denmark, 2000
2
Hvidovre Hospital
Copenhagen, Copenhagen, Denmark, 2650
3
Nordsjællands Hospital
Hillerød, Denmark
4
Roskilde Hospital
Roskilde, Denmark