Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT06709456
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2024-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D006935', 'term': 'Hypercapnia'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinding of statisticians.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Investigator-initiated, pragmatic, multicentre, open-label, randomised, parallel-group clinical feasibility trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention group separation (feasibility)', 'timeFrame': '90 days', 'description': 'Proportion of patients receiving pleural drainage during ICU stay'}], 'secondaryOutcomes': [{'measure': 'Protocol adhearence (feasibility)', 'timeFrame': '90 days', 'description': 'Proportion of patients with one or more protocol violations defined as:\n\n* Participants allocated to pleural drainage who do not receive this within 24 hours from randomisation.\n* 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.\n* 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).'}, {'measure': 'Recruitment proportion (feasibility)', 'timeFrame': 'Through trial completion, estimated at 1 year.', 'description': 'Proportion of included patients out of the number of eligible patients, i.e., patients who comply with all inclusion and exclusion criteria'}, {'measure': 'Loss to follow-up (feasibility)', 'timeFrame': '90 days', 'description': 'Proportion of participants without consent to the use of data'}, {'measure': 'All-cause mortality (clinical outcome)', 'timeFrame': '90 days', 'description': 'All-cause mortality'}, {'measure': 'Serious adverse events (clinical outcome)', 'timeFrame': '90 days', 'description': '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.'}, {'measure': 'Days alive without life support (clinical outcome)', 'timeFrame': '90 days', 'description': 'Absolute number of days alive without life support being the use of mechanical ventilation, renal replacement therapy, or circulatory support'}, {'measure': 'Days alive and out of hospital (clinical outcome)', 'timeFrame': '90 days', 'description': 'Absolute number of days alive and out of hospital'}, {'measure': 'Pleural infections (process outcome)', 'timeFrame': 'After 24 hours and within 90 days from randomisation', 'description': '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.'}, {'measure': '24-hour oxygenation (process outcome)', 'timeFrame': '24 hours', 'description': 'PaO2/FiO2 ratio in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.'}, {'measure': '72-hour oxygenation (process outcome)', 'timeFrame': '72 hours', 'description': 'PaO2/FiO2 ratio in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.'}, {'measure': '24-hour pH (process outcome)', 'timeFrame': '24 hours', 'description': 'pH in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.'}, {'measure': '72-hour pH (process outcome)', 'timeFrame': '72 hours', 'description': 'pH in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.'}, {'measure': '24-hour carbon dioxide (process outcome)', 'timeFrame': '24 hours', 'description': 'PaCO2 in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.'}, {'measure': '72-hour carbon dioxide (process outcome)', 'timeFrame': '72 hours', 'description': 'PaCO2 in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pleural effusion', 'Respiratory failure', 'Pleural drainage', 'Ultrasonography', 'Intensive Care Unit', 'Randomised clinical trial', 'Feasibility', 'Critical care', 'Hypoxaemia', 'Hypercapnia'], 'conditions': ['Pleural Effusions', 'Respiratory Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cric.nu/dope-icu', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Acute admission to the ICU.\n* Age ≥ 18 years.\n* 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).\n* 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.\n\nExclusion Criteria:\n\n* Mediastinal drain or pleural drain in situ on either side.\n* Suspected or confirmed haemothorax (e.g., due to recent thoracic trauma or intrathoracic surgery).\n* 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).\n* Suspected or confirmed pleural empyema (e.g., by anamnesis or clinical presentation, or on CT, MRI or ultrasonographic assessment).\n* Pleural malignancy (suspected or confirmed pleural lymphoma, pleural metastases or direct pleural invasion, or malignant mesothelioma).\n* Antithrombotic treatment or coagulation deficiency incompatible with conducting pleural drainage as by local recommendations, and contraindications to reversal of this (clinical assessment).\n* Clinically assessed absolute indication for therapeutic pleural drainage and:\n\n * invasive or non-invasive mechanical ventilation or mask CPAP with PaO2/FiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis.\n * 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.\n * 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.\n* Withdrawal from active therapy or brain death deemed imminent.\n* Expected ICU stay \\< 24 hours from randomisation.\n* 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).\n* Under coercive measures (i.e., ongoing involuntary hospital admission or under correctional authorities' jurisdiction).\n* Consent not obtainable as per Danish legislation.\n* Previously randomised in the DOPE-ICU feasibility trial."}, 'identificationModule': {'nctId': 'NCT06709456', 'briefTitle': 'Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'N-20240027'}, 'secondaryIdInfos': [{'id': 'FID4401466', 'type': 'OTHER_GRANT', 'domain': "Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis' legat"}, {'id': '2024-0049', 'type': 'OTHER_GRANT', 'domain': 'Region Nordjyllands Sundhedsvidenskabelige Forskningsfond'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pleural drainage', 'description': "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.", 'interventionNames': ['Procedure: Ultrasonography-guided pleural drainage']}, {'type': 'NO_INTERVENTION', 'label': 'No pleural drainage', 'description': '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': [{'name': 'Ultrasonography-guided pleural drainage', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Pleural drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Marie S Worm, MD', 'role': 'CONTACT', 'email': 'marie.worm@rn.dk', 'phone': '+45 97 66 19 24'}, {'name': 'Olav L Schjørring, MD, PhD', 'role': 'CONTACT', 'email': 'o.schjoerring@rn.dk', 'phone': '+45 97 66 19 21'}], 'facility': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten H Møller, MD, PhD', 'role': 'CONTACT', 'email': 'morten.hylander.moeller@regionh.dk', 'phone': '+45 35 45 86 85'}], 'facility': 'ICU department 4131, Copenhagen University Hospital, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '3400', 'city': 'Hillerød', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten H Bestle, MD, PhD', 'role': 'CONTACT', 'email': 'morten.bestle@regionh.dk', 'phone': '+45 48 29 20 17'}], 'facility': 'Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '6000', 'city': 'Kolding', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne C Brøchner, MD, PhD', 'role': 'CONTACT', 'email': 'anne.craveiro.broechner@rsyd.dk', 'phone': '+45 76 36 31 14'}], 'facility': 'Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}, {'zip': '4600', 'city': 'Køge', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lars PK Andersen, MD, PhD', 'role': 'CONTACT', 'email': 'lapan@regionsjaelland.dk', 'phone': '+45 56 63 15 00'}], 'facility': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'zip': '4000', 'city': 'Roskilde', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henrik P Pedersen, MD', 'role': 'CONTACT', 'email': 'hppd@regionsjaelland.dk', 'phone': '+45 46 32 32 00'}], 'facility': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'centralContacts': [{'name': 'Marie S Worm, MD', 'role': 'CONTACT', 'email': 'marie.worm@rn.dk', 'phone': '+45 97 66 19 24'}, {'name': 'Olav L Schjørring, MD, PhD', 'role': 'CONTACT', 'email': 'o.schjoerring@rn.dk', 'phone': '+45 97 66 19 21'}], 'overallOfficials': [{'name': 'Olav L Schjørring, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Study protocol with statistical analysis plan and informed consent forms are available on the webpage (www.cric.nu/dope-icu)', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Managed by the Steering Committee of the DOPE-ICU feasibility trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olav Schjørring', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Consultant, MD, PhD', 'investigatorFullName': 'Olav Schjørring', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}