Optimized Treatment of Pulmonary Edema or Congestion

Launched by JOHANNES GRAND · Mar 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat pulmonary edema, a condition where fluid builds up in the lungs and causes breathing difficulties. Specifically, it compares three treatment methods: using a medication called furosemide (a type of diuretic that helps remove excess fluid), using nitrates (which help relax blood vessels), or a combination of both. This research is important because current treatment guidelines mainly recommend diuretics, but there hasn’t been enough direct comparison with nitrates in emergency situations.

To be eligible for the trial, participants must be at least 18 years old and experiencing a sudden worsening of breathing difficulties, among other criteria. During the trial, which will last about 6 hours, participants will receive one of the three treatments quickly after being admitted to the hospital. The study aims to find out which treatment works best for relieving symptoms of pulmonary congestion. If any safety concerns arise, such as low blood pressure or insufficient urine output, the treatment will be paused, and standard care will be provided. This trial is currently recruiting participants, and it welcomes individuals of all genders who meet the eligibility requirements.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Age ≥ 18 years
• • 2. Acute (within minutes to days) onset or worsening of subjective dyspnea\*
• • 3. Systolic blood pressure ≥100 mmHg
• • 4. Oxygen saturation \<94% or need of oxygen
• • 5. 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
• • 1. More than 40 mg IV furosemide within the last three hours before randomization including prehospital treatment.
• • 2. More than 3 hours from hospital-admission to randomization
• • 3. Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \> 180 or \< 40 bpm.
• • 4. 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