Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial

NCT ID: NCT06709456

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-10-31

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.

Detailed Description

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.

Conditions

Pleural Effusions; Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pleural drainage

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.

Group Type: EXPERIMENTAL

Ultrasonography-guided pleural drainage

Intervention Type: PROCEDURE

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.

No 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ultrasonography-guided pleural drainage

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 Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Olav Schjørring

OTHER

Sponsor Role: lead

Responsible Party

Olav Schjørring

Associate Professor, Consultant, MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Olav L Schjørring, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark

Locations

Department of Anaesthesia and Intensive Care, Aalborg University Hospital

Aalborg, , Denmark

Site Status: RECRUITING

ICU department 4131, Copenhagen University Hospital, Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød

Hillerød, , Denmark

Site Status: RECRUITING

Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding

Kolding, , Denmark

Site Status: RECRUITING

Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge

Køge, , Denmark

Site Status: NOT_YET_RECRUITING

Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde

Roskilde, , Denmark

Site Status: NOT_YET_RECRUITING

Countries

Denmark

Central Contacts

Marie S Worm, MD

Role: CONTACT

marie.worm@rn.dk

+45 97 66 19 24

Olav L Schjørring, MD, PhD

Role: CONTACT

o.schjoerring@rn.dk

+45 97 66 19 21

Facility Contacts

Marie S Worm, MD

Role: primary

marie.worm@rn.dk

+45 97 66 19 24

Olav L Schjørring, MD, PhD

Role: backup

o.schjoerring@rn.dk

+45 97 66 19 21

Morten H Møller, MD, PhD

Role: primary

morten.hylander.moeller@regionh.dk

+45 35 45 86 85

Morten H Bestle, MD, PhD

Role: primary

morten.bestle@regionh.dk

+45 48 29 20 17

Anne C Brøchner, MD, PhD

Role: primary

anne.craveiro.broechner@rsyd.dk

+45 76 36 31 14

Lars PK Andersen, MD, PhD

Role: primary

lapan@regionsjaelland.dk

+45 56 63 15 00

Henrik P Pedersen, MD

Role: primary

hppd@regionsjaelland.dk

+45 46 32 32 00

Related Links

http://www.cric.nu/dope-icu

Related Info

Other Identifiers

FID4401466

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-0049

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N-20240027

Identifier Type: -

Identifier Source: org_study_id