[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570910":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":66,"collaborators":12,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":12,"enrollmentInfo":78,"targetDuration":12,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","NO_INTERVENTION","Patients will receive the current standard of care, which includes antibiotics, chest tube placement, and intrapleural tPA\u002FDNase therapy based on their clinical criteria",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Standard Care + Saline Irrigation","EXPERIMENTAL","In addition to the standard care, patients in this group will receive pleural saline irrigation through the chest tube immediately after IPFT. The amount of saline will be determined by free-flow saline infusion up to 250 mL. This maneuver will be repeated every time that IPFT is administered, based on treating physician's criteria",[18],"Combination Product: Pleural Saline Irrigation",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"COMBINATION_PRODUCT","Pleural Saline Irrigation","This intervention, Pleural Saline Irrigation, involves the administration of up to 250 mL of sterile saline solution into the pleural cavity through a chest tube immediately following each intrapleural tPA\u002FDNase (IPFT) therapy session. The saline irrigation is intended to aid in clearing infected pleural fluid and reducing pleural effusion volume. This maneuver is repeated based on the treating physician's criteria, differentiating it from standard care, which includes only antibiotics, chest tube placement, and IPFT without saline irrigation. The irrigation is expected to enhance infection resolution and may impact chest tube duration and the frequency of pleural interventions.",[14],[26],{"name":27,"affiliation":5,"role":28},"Adnan Majid, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":12,"email":33},"CONTACT","6179016430","amajid@bidmc.harvard.edu",{"name":35,"role":31,"phone":36,"phoneExt":12,"email":37},"Maria C Lopez, MD","7869678448","mlopezgi@bidmc.harvard.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-71.05977,42.35843,{"lat":50,"lon":49},[53,54,55,58,60,62,64],{"name":27,"role":31,"phone":32,"phoneExt":12,"email":33},{"name":27,"role":28,"phone":12,"phoneExt":12,"email":12},{"name":56,"role":57,"phone":12,"phoneExt":12,"email":12},"Maria C Lopez Giron, MD","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":12,"phoneExt":12,"email":12},"Marta A Diez, MD",{"name":61,"role":57,"phone":12,"phoneExt":12,"email":12},"Kai E Swenson, MD",{"name":63,"role":57,"phone":12,"phoneExt":12,"email":12},"Mihir Parikh, MD",{"name":65,"role":57,"phone":12,"phoneExt":12,"email":12},"Jason A Beattie, MD",{"type":28,"investigatorFullName":27,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Medical Doctor","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":79,"type":80},96,"ESTIMATED","INTERVENTIONAL",[83],"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.",[86,87,88],"Pleural Effusion Associated With Pulmonary Infection","Pleural Effusion Disorder","Pleural Effusions",[90,91,92,93,94],"Pleural Effusion","Thoracentesis","Tissue Plasminogen Activator","DNase","Therapeutic Irrigation","2025-05-21",{"date":97,"type":98},"2025-05-25","ACTUAL",{"date":100,"type":98},"2025-04-10",{"date":102,"type":80},"2026-12-20",{"name":5,"class":6},1]