NCT06709456 Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial
| NCT ID | NCT06709456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Olav Schjørring |
| Condition | Pleural Effusions |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 88 participants in total. It began in 2024-12-02 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Acute admission to the ICU. * Age ≥ 18 years. * Pleural effusion ≥ 2 cm in either pleural cavity assessed by ultrasonography, computed tomography or magnetic resonance imaging (measured between the parietal and visceral pleura perpendicularly to the chest wall at the largest-separation point). * Respiratory failure defined as one or more of the following: any oxygen supplementation in an open system, invasive or non-invasive mechanical ventilation (including non-intermittent mask CPAP), or most recent arterial blood gas analysis with arterial partial pressure of carbon dioxide (PaCO2) \> 6.0 kPa and pH \< 7.35. Exclusion Criteria: * Mediastinal drain or pleural drain in situ on either side. * Suspected or confirmed haemothorax (e.g., due to recent thoracic trauma or intrathoracic surgery). * Suspected or confirmed pneumothorax (e.g., by anamnesis, on radiographic or ultrasonographic assessment, or by clinical presentation, e.g., due to presence of subcutaneous emphysema). * Suspected or confirmed pleural empyema (e.g., by anamnesis or clinical presentation, or on CT, MRI or ultrasonographic assessment). * Pleural malignancy (suspected or confirmed pleural lymphoma, pleural metastases or direct pleural invasion, or malignant mesothelioma). * Antithrombotic treatment or coagulation deficiency incompatible with conducting pleural drainage as by local recommendations, and contraindications to reversal of this (clinical assessment). * Clinically assessed absolute indication for therapeutic pleural drainage and: * invasive or non-invasive mechanical ventilation or mask CPAP with PaO2/FiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis. * high-flow humidified oxygen therapy with a flow ≥ 50 L/min and a PaO2/FiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis. * persistent respiratory acidosis with a pH \< 7.25 and a PaCO2 \> 6.0 kPa in the most recent ABG analysis in spite of non-invasive ventilation for \> 1 hour. * Withdrawal from active therapy or brain death deemed imminent. * Expected ICU stay \< 24 hours from randomisation. * Pregnancy (in females \< 60 years of age, non-pregnancy must be confirmed by a negative urine or plasma human chorionic gonadotropin, or presence a condition incompatible with pregnancy, e.g., previous hysterectomy, or conducted caesarean section during current hospitalisation). * Under coercive measures (i.e., ongoing involuntary hospital admission or under correctional authorities' jurisdiction). * Consent not obtainable as per Danish legislation. * Previously randomised in the DOPE-ICU feasibility trial.
Contact & Investigator
Olav L Schjørring, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark
Frequently Asked Questions
Who can join the NCT06709456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Effusions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06709456 currently recruiting?
Yes, NCT06709456 is actively recruiting participants. Contact the research team at marie.worm@rn.dk for enrollment information.
Where is the NCT06709456 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Copenhagen, Denmark, Hillerød, Denmark, Kolding, Denmark and 2 additional locations.
Who is sponsoring the NCT06709456 clinical trial?
NCT06709456 is sponsored by Olav Schjørring. The principal investigator is Olav L Schjørring, MD, PhD at Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark. The trial plans to enroll 88 participants.