Clinical trial NCT06709456: Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial
Official title: Drainage of Pleural Effusions in the Intensive Care Unit in Adults With Respiratory Failure: A Randomised Clinical Feasibility Trial of Performing Versus Withholding Pleural Drainage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pleural Effusions
Respiratory Failure
Keywords: Pleural effusion
Respiratory failure
Pleural drainage
Ultrasonography
Intensive Care Unit
Randomised clinical trial
Feasibility
Critical care
Hypoxaemia
Hypercapnia
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2024-11-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator-initiated, pragmatic, multicentre, open-label, randomised, parallel-group clinical feasibility trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intervention group separation (feasibility)
timeFrame: 90 days
Secondary outcomes:
measure: Protocol adhearence (feasibility)
timeFrame: 90 days
measure: Recruitment proportion (feasibility)
timeFrame: Through trial completion, estimated at 1 year.
measure: Loss to follow-up (feasibility)
timeFrame: 90 days
measure: All-cause mortality (clinical outcome)
timeFrame: 90 days
measure: Serious adverse events (clinical outcome)
timeFrame: 90 days
measure: Days alive without life support (clinical outcome)
timeFrame: 90 days
measure: Days alive and out of hospital (clinical outcome)
timeFrame: 90 days
measure: Pleural infections (process outcome)
timeFrame: After 24 hours and within 90 days from randomisation
measure: 24-hour oxygenation (process outcome)
timeFrame: 24 hours
measure: 72-hour oxygenation (process outcome)
timeFrame: 72 hours
measure: 24-hour pH (process outcome)
timeFrame: 24 hours
measure: 72-hour pH (process outcome)
timeFrame: 72 hours
measure: 24-hour carbon dioxide (process outcome)
timeFrame: 24 hours
measure: 72-hour carbon dioxide (process outcome)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Anaesthesia and Intensive Care, Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: ICU department 4131, Copenhagen University Hospital, Rigshospitalet
city: Hillerød
country: Denmark
facility: Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød
city: Kolding
country: Denmark
facility: Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding
city: Køge
country: Denmark
facility: Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge
city: Roskilde
country: Denmark
facility: Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde
Study officials:
affiliation: Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark
name: Olav L Schjørring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: