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

NCT06709456 | Recruiting

• 3 other identifiers: N-20240027FID44014662024-0049
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 6

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.

Conditions

Pleural Effusions; Respiratory Failure

Keywords

Pleural effusion; Respiratory failure; Pleural drainage; Ultrasonography; Intensive Care Unit; Randomised clinical trial; Feasibility; Critical care; Hypoxaemia; Hypercapnia

Outcome Measures

Primary Outcomes (1)

• Intervention group separation (feasibility)

  Proportion of patients receiving pleural drainage during ICU stay

  90 days

Secondary Outcomes (14)

• Protocol adhearence (feasibility)

  90 days

• Recruitment proportion (feasibility)

  Through trial completion, estimated at 1 year.

• Loss to follow-up (feasibility)

  90 days

• All-cause mortality (clinical outcome)

  90 days

• Serious adverse events (clinical outcome)

  90 days

Study Arms (2)

Pleural drainage

EXPERIMENTAL

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

NO INTERVENTION

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.

Interventions

Ultrasonography-guided pleural drainage 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.

Pleural drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Olav Schjørring: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (6)

Department of Anaesthesia and Intensive Care, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

ICU department 4131, Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

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

Hillerød, 3400, Denmark

RECRUITING

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

Kolding, 6000, Denmark

RECRUITING

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

Køge, 4600, Denmark

NOT YET RECRUITING

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

Roskilde, 4000, Denmark

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Pleural Effusion; Respiratory Insufficiency; Hypoxia; Hypercapnia

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olav L Schjørring, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie S Worm, MD

CONTACT

+45 97 66 19 24; marie.worm@rn.dk

Olav L Schjørring, MD, PhD

CONTACT

+45 97 66 19 21; o.schjoerring@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of statisticians.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Consultant, MD, PhD

Model Details: Investigator-initiated, pragmatic, multicentre, open-label, randomised, parallel-group clinical feasibility trial

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 29, 2024
• Study Start: December 2, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

DK (6)