[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pleural-effusions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pleural-effusions":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100570910","phase-2-evaluating-the-efficacy-and-safety-of-saline-irrigation-as-an-add-on-therapy-for-retained-pleural-infections-lytics--100570910",false,"NCT06713382","Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]","Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections (LYTICS +)","[LYTICS+]","Inclusion Criteria:\n\n* Age ≥18 years.\n* Presence of purulent pleural fluid or pleural fluid analysis with any of the following:\n* pH ≤ 7.2.\n* Glucose \\\u003C 40 mg\u002FdL.\n* LDH \\> 1000 IU\u002FL.\n* Presence of bacterial or fungal organisms on Gram stain or culture.\n* Chest tube placement with less than 200 mL drainage in 24 hours.\n* Indication for IPFT treatment based on treating physician's criteria.\n* Radiographic evidence of septations on chest ultrasound (US) or loculations on low-dose chest computed tomography (CT).\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Pregnant patients.\n* Patients with significant comorbidities that may interfere with the study -outcomes (e.g., terminal malignancy).\n* Complicated sympathetic effusion.\n* Hepatic hydrothorax.","ALL","18 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this protocol is to conduct a pilot prospective non-blind clinical trial to evaluate the efficacy and safety of a novel saline irrigation technique as an adjunct to standard interventions for treating retained pleural infections. Intrapleural fibrinolytic therapy (IPFT) is commonly used for infections not adequately managed with antibiotics and intercostal tube drainage, while saline irrigation serves as an alternative for cases with a high bleeding risk where IPFT is not feasible. The efficacy of saline irrigation combined with IPFT remains unexplored. The hypothesis is that saline irrigation could be an effective and safe addition to IPFT for patients with persistent pleural infections.\n\nThe specific aims of the study include:\n\nDetermine the efficacy of saline irrigation as add-on therapy to IPFT: Compare the clinical outcomes of patients receiving saline irrigation combined with IPFT to those receiving IPFT alone to determine if the addition of saline irrigation offers significant benefits. Outcomes include changes in inflammatory markers, imaging characteristics (echography and CT), volume of pleural fluid drained, chest tube duration, hospital length of stay, and the need for subsequent surgical intervention.\n\nAssess the safety and tolerability of saline irrigation plus IPFT: Compare complications and patient comfort in those receiving saline irrigation combined with IPFT to those receiving IPFT alone.",[27,28,29],"Pleural Effusion Associated With Pulmonary Infection","Pleural Effusion Disorder","Pleural Effusions",[31,32,33,34,35],"Pleural Effusion","Thoracentesis","Tissue Plasminogen Activator","DNase","Therapeutic Irrigation","RECRUITING","2025-05-21",{"date":39,"type":40},"2025-05-25","ACTUAL",{"date":42,"type":40},"2025-04-10",{"date":44,"type":21},"2026-12-20",{"name":46,"class":47},"Beth Israel Deaconess Medical Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100570608","drainage-of-pleural-effusions-in-the-intensive-care-unit-dope-icu---feasibility-trial-100570608","NCT06709456","Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial","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","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 \\\u003C 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\u002FFiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis.\n  * high-flow humidified oxygen therapy with a flow ≥ 50 L\u002Fmin and a PaO2\u002FFiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis.\n  * persistent respiratory acidosis with a pH \\\u003C 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 \\\u003C 24 hours from randomisation.\n* Pregnancy (in females \\\u003C 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.",{"count":57,"type":21},88,[59],"NA","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.",[29,62],"Respiratory Failure",[64,65,66,67,68,69,70,71,72,73],"Pleural effusion","Respiratory failure","Pleural drainage","Ultrasonography","Intensive Care Unit","Randomised clinical trial","Feasibility","Critical care","Hypoxaemia","Hypercapnia","2025-04-09",{"date":76,"type":40},"2025-04-11",{"date":78,"type":40},"2024-12-02",{"date":80,"type":21},"2025-10",{"name":82,"class":47},"Olav Schjørring",6]