[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complicated-pleural-effusion-empyema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complicated-pleural-effusion-empyema":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100600274","phase-4-once-daily-intrapleural-enzyme-therapy-in-complicated-parapneumonic-effusion-or-empyema-100600274",false,"NCT07095361","Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema","Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)","ONLY ONCE","Inclusion Criteria:\n\n* Written informed consent obtained from patient or patient's legally authorized representative (LAR) to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.\n* Age ≥ 18 years at the time of consent.\n* Patient is admitted to the hospital and with a pleural effusion that is drained with a small-bore chest tube or one that allows for administration of IET\n* Pleural fluid that is one of the following:\n\n  (i) Macroscopically purulent or pleural fluid gram stain or culture positive for bacteria (ii) potential of hydrogen (pH) \\\u003C 7.2 (iii) Pleural fluid glucose \\\u003C 60mg\u002FdL (iv) Pleural fluid Lactate Dehydrogenase (LDH) \\> 1,000 IU\u002FL\n* Patient is deemed a candidate to receive intrapleural enzyme therapy as defined by having a residual collection or persistent sepsis 24 hours after initial chest tube placement\n\nExclusion Criteria:\n\n* Known pregnancy or lactating females\n* Prisoners\n* Age \\\u003C18 years at time of consent\n* Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission\n* Known sensitivity or allergic reaction to DNAse or tPA\n* Coincidental stroke, major hemorrhage (requiring blood transfusions within the last 5 days), major trauma, or major surgery within the last 5 days\n* Previous pneumonectomy or active bronchopleural fistula on the affected side\n* Therapeutic systemic anticoagulation or antiplatelet agents that cannot held for more than 48 hours prior to IET administration\n* Expected survival of less than 3 months due to a pathologic condition other than that causing the pleural infection","ALL","18 Years",{"count":20,"type":21},270,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to find out if giving certain medications once a day works just as well as giving them twice a day to treat infections around the lungs (called pleural infections). These medications-tissue plasminogen activator (tPA) and deoxyribonuclease (DNase)-are placed through a chest tube into the space between the lung and the chest wall to help clear out the infection.\n\nThe investigators are trying to learn:\n\n* Does using the medicine once a day work just as well as using it twice a day?\n* Are there any differences in outcomes between patients who get the medicine once a day versus twice a day?\n* Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?\n\nParticipants will:\n\n* Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung.\n* Be asked to give permission to join the study.\n* Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.",[27,28,29,30,31,32,33,34],"Pleural Infection Bacterial","Pleural Infections","Pleural Infections and Inflammations","Empyema, Pleural","Empyema","Complicated Pleural Effusion\u002F Empyema","Pleural Effusion Associated With Pulmonary Infection","Pleural Effusion",[36,37,38,39],"Lytics","Intrapleural enzyme therapy","Once daily","lytic therapy","RECRUITING","2026-05-14",{"date":43,"type":44},"2026-05-19","ACTUAL",{"date":46,"type":44},"2025-09-11",{"date":48,"type":21},"2028-09-30",{"name":50,"class":51},"University of North Carolina, Chapel Hill","OTHER",6,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100572531","effectiveness-and-safety-of-sodium-bicarbonate-pleural-lavage-in-the-treatment-of-complex-pleural-effusion-100572531","NCT06734481","Effectiveness and Safety of Sodium Bicarbonate Pleural Lavage in the Treatment of Complex Pleural Effusion","Effectiveness and Safety of Sodium Bicarbonate Pleural Lavage in the Treatment of Complex Pleural Effusion: Protocol for a Multicenter Randomized Controlled Trial（SAPLIC Study）","SAPLIC","Inclusion Criteria:\n\n* Hospitalized patients aged 18 to 80 years, inclusive.\n* Patients fulfilling any one of the following three criteria for complicated pleural effusion: A. Pleural fluid pH \\\u003C 7.2; B. Pleural fluid glucose \\\u003C 2.2 mmol\u002FL and LDH \\> 1000 IU\u002FL; C. Positive pleural fluid culture or smear for pathogens.\n* Pleural effusion volume exceeding 300 mL, as determined by CT imaging using the formula D\\^2 \\* L (where D represents the maximum depth and L the maximum length), and for whom pleural effusion drainage is clinically indicated according to established guidelines or criteria.\n\nExclusion Criteria:\n\n* Patients with known allergies to sodium bicarbonate or normal saline.\n* Patients with severe coagulation disorders.\n* Patients with severe heart or kidney failure.\n* Pregnant or lactating women.\n* Patients with pleural effusion caused by hospital-acquired interference, tuberculosis, fungal infections, or non-infectious causes.\n* Patients unable to tolerate intrapleural administration.\n* Patients with chronic lung diseases that may affect antibiotic efficacy, such as uncontrolled chronic obstructive pulmonary disease (COPD GOLD E group), bronchiectasis, or immunodeficiency.\n* Patients who have experienced shock, major bleeding, trauma, or pulmonary surgery within the past 5 days.\n* Patients with a history of lung or pleural surgery on the side of the pleural effusion.\n* Patients who have recently had chest tubes placed due to pneumothorax, surgery, or pleural effusion.\n* Patients currently enrolled in another drug or device clinical trial.\n* Patients with poor compliance or difficulty in follow-up, or those with an expected survival of less than 3 months due to conditions other than pleural effusion.","80 Years",{"count":63,"type":21},260,[65],"NA","The goal of this clinical trial is to evaluate the safety and efficacy of sodium bicarbonate pleural lavage in treating complex pleural effusion in adult. The main questions it aims to answer are:\n\nWill sodium bicarbonate pleural lavage reduce the failure rate of medical treatment (referral rate for surgery) for complicated pleural effusion？ Can sodium bicarbonate pleural lavage accelerating the rehabilitation of patients with complicated pleural effusion？ Will sodium bicarbonate pleural lavage improve the prognosis of patients with complicated pleural effusion?\n\nParticipants will will undergo catheter placement for continuous drainage of pleural effusion. Once at least 200 mL of pleural effusion has been drained:\n\nGroup A: Participants will receive a daily intrapleural injection of 200 mL of saline in 7 days; Group B: Participants will receive a daily intrapleural injection of 200 mL of 2.5% sodium bicarbonate in 7 days.",[32],"2024-12-12",{"date":70,"type":44},"2024-12-16",{"date":72,"type":44},"2024-04-01",{"date":74,"type":21},"2026-08-01",{"name":76,"class":77},"First Affiliated Hospital of Ningbo University","NETWORK",1]