Actively Recruiting
Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial
Led by Olav Schjørring · Updated on 2025-04-11
88
Participants Needed
6
Research Sites
43 weeks
Total Duration
On this page
Sponsors
O
Olav Schjørring
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial evaluates the feasibility of ultrasound-guided pleural drainage versus no drainage in adult ICU patients with pleural effusions (fluid buildup around the lungs) and respiratory failure. Half of the patients will undergo drainage, while the other half will not unless their condition worsens to a prespecified degree. Outcomes include feasibility measures, clinical parameters, mortality, serious adverse events, and life support use over 90 days.
CONDITIONS
Official Title
Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute admission to the ICU
- Age 18 years or older
- Pleural effusion of 2 cm or more in either pleural cavity measured by ultrasound, CT, or MRI
- Respiratory failure defined by oxygen supplementation, mechanical ventilation, or recent arterial blood gas with PaCO2 > 6.0 kPa and pH < 7.35
You will not qualify if you...
- Presence of mediastinal or pleural drain on either side
- Suspected or confirmed haemothorax
- Suspected or confirmed pneumothorax
- Suspected or confirmed pleural empyema
- Pleural malignancy such as lymphoma, metastases, or mesothelioma
- Antithrombotic treatment or coagulation issues preventing drainage
- Absolute indication for therapeutic drainage with severe respiratory failure or acidosis despite ventilation
- Withdrawal from active therapy or imminent brain death
- Expected ICU stay less than 24 hours from randomisation
- Pregnancy in females under 60 years unless confirmed negative by tests or incompatible condition
- Under coercive measures or involuntary admission
- Consent cannot be obtained according to Danish law
- Previously participated in this trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Department of Anaesthesia and Intensive Care, Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
2
ICU department 4131, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød
Hillerød, Denmark, 3400
Actively Recruiting
4
Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding
Kolding, Denmark, 6000
Actively Recruiting
5
Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge
Køge, Denmark, 4600
Not Yet Recruiting
6
Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde
Roskilde, Denmark, 4000
Not Yet Recruiting
Research Team
M
Marie S Worm, MD
CONTACT
O
Olav L Schjørring, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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