An interventional study of Ultrasonography-guided pleural drainage in Pleural Effusions and Respiratory Failure, sponsored by Olav Schjørring. Recruiting at 6 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Olav Schjørring · Not applicable, Interventional, and Treatment
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.
Pleural effusions are common in intensive care unit (ICU) patients and are often treated with fluid drainage guided by ultrasonography. While this can improve oxygenantion levels, it is unclear whether it leads to better overall outcomes, and the procedure carries risks such as bleeding or lung collapse. There is limited evidence and no randomised trials supporting this procedure in ICU patients with respiratory failure. The DOPE-ICU feasibility trial will assess the feasibility of evaluating pleural drainage in such patients. Eligible ICU patients will be randomly assigned to either receive drainage or no drainage unless their condition worsens to a prespecified degree. Feasibility outcomes include the proportion of patients receiving drainage, protocol adherence, and proportion of patients with consent withdrawal for follow-up. Clinical outcomes include death rates, serious adverse events, and life support use, all within 90 days. Process outcomes include oxygenation, pH and arterial carbon dioxide tension at prespecified time points. The trial aims to determine whether a larger, more definitive trial is feasible.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 88 is close to the median of 80 across 142 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →This is the only study on the registry with Olav Schjørring as lead sponsor.
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Exclusion Criteria:
Clinically assessed absolute indication for therapeutic pleural drainage and:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultrasonography-guided pleural drainage with insertion of a small-bore intrapleural catheter (typically pig-tail type catheter, size 6-14 French), conducted by e.g., intensivists or radiologists, as by local standards, of the pleural cavity with the estimated largest pleural effusion as soon as possible. A time interval of up to 24 hours from randomisation to intervention is expected. If bilateral pleural effusions ≥ 2 cm are present at randomisation, drainage of contralateral pleura should be conducted as soon as possible according to local standards, at least within 24 hours from insertion of the first pleural catheter unless pleural effusion has receded to \< 2 cm prior to drainage. Inserted pleural catheters remain connected to a closed pleural drainage system, in situ and open until removed at clinicians' discretion according to local standards. New pleural effusion ≥ 2 cm during ICU stay within 90 days from randomisation will be drained similarly.
Procedure: Ultrasonography-guided pleural drainage
No pleural drainage is conducted during ICU stay in 90 days from randomisation, unless escape protocol criteria are present being suspected or confirmed haemothorax, suspected or confirmed pneumothorax, suspected or confirmed pleural empyema, suspected or confirmed pleural malignancy, or indication for therapeutic pleural drainage as per the treating clinician and invasive or non-invasive mechanical ventilation or mask CPAP with arterial partial pressure of oxygen to fraction of inspired oxygen (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, or persistent respiratory acidosis with a pH \< 7.25 and an arterial partial pressure of carbon dioxide (PaCO2) \> 6.0 kPa on the most recent ABG analysis in spite of non-invasive ventilation for \> 1 hour.
Ultrasonography-guided pleural drainage with insertion of a small-bore intrapleural catheter. Contralateral and repeated drainage conducted as specified during ICU stay until day 90.
Intervention group separation (feasibility)
Proportion of patients receiving pleural drainage during ICU stay
Time frame: 90 days
Protocol adhearence (feasibility)
Proportion of patients with one or more protocol violations defined as: * Participants allocated to pleural drainage who do not receive this within 24 hours from randomisation. * Participants allocated to pleural drainage with bilateral pleural effusion who do not receive the second (contralateral) pleural drainage within 24 hours from the primary drainage, unless pleural effusion has receded \< 2 cm. * Participants allocated to no pleural drainage who receive pleural drainage at any time during ICU stay within 90 days from randomisation, including ICU readmissions, except when escape criteria for pleural drainage are present as specified (se "No intervention" arm).
Time frame: 90 days
Recruitment proportion (feasibility)
Proportion of included patients out of the number of eligible patients, i.e., patients who comply with all inclusion and exclusion criteria
Time frame: Through trial completion, estimated at 1 year.
Loss to follow-up (feasibility)
Proportion of participants without consent to the use of data
Time frame: 90 days
All-cause mortality (clinical outcome)
All-cause mortality
Time frame: 90 days
Serious adverse events (clinical outcome)
Proportion of patients with one or more serious adverse events (SAEs); SAEs are defined as new pneumothorax requiring invasive treatment (drainage or surgery), new haemothorax requiring red blood cell transfusion, new blood stream infection defined as any cultured microorganism from any blood sample except microorganisms clearly specified to be contaminants or likely contaminants by the microbiological department, and new episode of invasive mechanical ventilation defined as endotracheal intubation or re-intubation after extubation or tracheal decannulation.
Time frame: 90 days
Days alive without life support (clinical outcome)
Absolute number of days alive without life support being the use of mechanical ventilation, renal replacement therapy, or circulatory support
Time frame: 90 days
Days alive and out of hospital (clinical outcome)
Absolute number of days alive and out of hospital
Time frame: 90 days
Pleural infections (process outcome)
Proportion of patients with new pleural infection after 24 hours from randomisation defined as any positive pleural fluid culture of any fungi or bacteria in any pleural fluid sampling conducted, except coagulase-negative Staphylococci, Enterococci, and Corynebacterium species, which will be considered contaminants.
Time frame: After 24 hours and within 90 days from randomisation
24-hour oxygenation (process outcome)
PaO2/FiO2 ratio in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.
Time frame: 24 hours
72-hour oxygenation (process outcome)
PaO2/FiO2 ratio in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.
Time frame: 72 hours
24-hour pH (process outcome)
pH in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.
Time frame: 24 hours
72-hour pH (process outcome)
pH in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.
Time frame: 72 hours
24-hour carbon dioxide (process outcome)
PaCO2 in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.
Time frame: 24 hours
72-hour carbon dioxide (process outcome)
PaCO2 in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.
Time frame: 72 hours
Plan to share: Yes — All original records (incl. consent forms, eCRFs, and relevant correspondences) will be archived at trial sites for 15 years. Anonymised data can be shared after primary publication upon specific request to the DOPE-ICU feasibility trial Steering Committee.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Study protocol with statistical analysis plan and informed consent forms are available on the webpage (www.cric.nu/dope-icu)
Access criteria: Managed by the Steering Committee of the DOPE-ICU feasibility trial.
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