[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-transplant-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-transplant-complications":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,68,94,115,137,160],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100493715","phase-2-cmv-immunity-monitoring-in-lung-transplant-recipients-100493715",false,"NCT05708755","CMV Immunity Monitoring in Lung Transplant Recipients","Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients","Inclusion Criteria:\n\n1. Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health\n2. Pre-existing serological immunity to CMV (R+)\n3. Able and willing to provide informed consent\n\nExclusion Criteria:\n\n1. Anti-thymocyte globulin induction immunosuppression\n2. Perioperative desensitization\n3. Pregnant or breastfeeding women","ALL","18 Years","99 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.",[27],"Lung Transplant; Complications","RECRUITING","2026-05-27",{"date":31,"type":32},"2026-05-29","ACTUAL",{"date":34,"type":32},"2024-09-13",{"date":36,"type":21},"2028-05",{"name":38,"class":39},"NYU Langone Health","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100398569","early-phase-1-early-use-of-long-acting-tacrolimus-in-lung-transplant-recipients-100398569","NCT04469842","Early Use of Long-acting Tacrolimus in Lung Transplant Recipients","A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients","Inclusion Criteria:\n\n* Status-post single or bilateral lung transplantation\n* Participant is able to give informed consent for participation in the study.\n* Male or female age 18 years or above.\n* Actively receives care at VUMC and is adherent with medical therapies.\n\nExclusion Criteria:\n\n* History of prior organ transplantation\n* History of tacrolimus use prior to transplantation\n* Intolerance of tacrolimus (that precludes use)\n* Having DSA pre-transplant (Positive virtual crossmatch)\n* Active infection with Hepatitis B or C\n* Active infection with Human Immunodeficiency Virus (HIV)\n* Baseline AST \u002F ALT \\> three times upper limit normal\n* Primary graft dysfunction grade 3 at 72 hours\n* Acute kidney injury during index hospitalization that does not resolve to two times the pre-transplant baseline value.\n* Contraindication to PO (per os) intake of medications\n* Impaired GI absorption (defined as sublingual administration of IR-tacro)\n* History of frequent headaches\n* Seizure history\n* Cannot provide consent (at least verbally)\n* Pregnancy or breast-feeding\n* Participation in another interventional clinical trial",{"count":49,"type":21},48,[51],"EARLY_PHASE1","Lung transplantation is a life-saving therapy for patients with advanced lung disease, however, necessitates the use of life-long immunosuppressive therapy for the prevention of acute and chronic rejection. The backbone of immunosuppression is the calcineurin-inhibitor class, with tacrolimus being the preferred drug due to its potency and improved side-effect profile. Nevertheless, tacrolimus is associated with several side effects including increased risk for infection and malignancy, tremors, headaches, seizures, hypertension, leukopenia and renal dysfunction. In fact, by 6 months post-transplant, 50% of patients will have a 50% decline in eGFR and by 5 years post-transplant \\~10% of patients will have advanced renal disease that may require renal replacement therapy and\u002For kidney transplantation. Tacrolimus induces a nephropathy in two ways- acute calcineurin inhibitor nephrotoxicity (CIN) is mediated by afferent arteriolar vasoconstriction, whereas chronic CIN is due to interstitial nephritis and fibrosis. Immunosuppressive regimens that spare or dose-reduce calcineurin inhibitors have been shown to have a modest impact on preserving renal function, but are limited by timing. Although most studies support implementing renal preserving protocols early on, this is balanced by the potential for acute cellular rejection, antibody mediated rejection and anastomotic dehiscence.\n\nLong-acting Tacrolimus (LCP-tacrolimus) may have the potential to bridge the balance of providing potent immunosuppression, while sparing renal function, due to the better systemic dose levels and improved concentration\u002Fdose ration achieved with it compared to IR-tacrolimus, evidenced in the renal transplant population. There is limited experience with LCP-tacrolimus in lung transplantation. Several case reports chronicling the late conversion from IR-tacrolimus to LCP-tacrolimus due to absorption issues or side-effect intolerance, have demonstrated safety and tolerability. The investigators seek to determine whether early use of LCP-tacrolimus in lung transplant recipients following the index hospitalization is acceptable, and propose a single-center prospective, randomized, controlled pilot study of early-use LCP-tacrolimus in lung transplant recipients to assess safety, tolerability and side-effects of LCP-tacrolimus.",[27],[55,56,57,58],"Lung Transplantation","Calcineurin inhibitor","LCP-tacrolimus (Envarsus XR)","Calcineurin-inhibitor nephrotoxicity (CIN)","2026-05-14",{"date":61,"type":32},"2026-05-15",{"date":63,"type":32},"2023-12-01",{"date":65,"type":21},"2027-12-31",{"name":67,"class":39},"Vanderbilt University Medical Center",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100546773","prospective-multicenter-research-on-donor-and-recipient-management-strategies-to-improve-lung-transplant-outcomes-100546773","NCT06399302","Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes","Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study","PROMISE","Inclusion Criteria:\n\n1. Able to understand and provide informed consent\n2. ≥ 18 years of age at the time of written informed consent\n3. Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days\n\n   * Participants undergoing repeat lung transplantation or multi-organ transplantation are eligible if they meet the inclusion\u002Fexclusion criteria.\n\nExclusion Criteria:\n\n1. Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol\n2. Pregnancy or plans to become pregnant\n3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.",{"count":77,"type":21},2600,"OBSERVATIONAL","This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions.",[27,81,82,83],"Lung Transplant; Infection or Inflammation","Lung Transplant Rejection","Lung Transplant Failure","2026-05-07",{"date":86,"type":32},"2026-05-11",{"date":88,"type":32},"2024-09-03",{"date":90,"type":21},"2027-06-30",{"name":92,"class":39},"Duke University",19,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":40},"100503566","association-between-renal-regional-oxygen-saturation-measured-by-near-infrared-spectroscopy-and-postoperative-renal-failure-after-lung-transplantation-surgery-a-pilot-study-100503566","NCT05836922","Association Between Renal Regional Oxygen Saturation Measured by Near-InfraRed Spectroscopy and Postoperative Renal Failure After Lung Transplantation Surgery: A Pilot Study","SO-AKI-TP","Inclusion Criteria:\n\n* patient undergoing a lung transplant (mono or bi-transplantation)\n* Age \\>= 18 years\n* Affiliated to the French social security system\n\nExclusion Criteria:\n\n* Renal anatomical abnormality likely to induce a misleading NIRS signal: single kidney, polycystic kidney disease.\n* Expression of opposition to participation in the research protocol.\n* Hyperbilurbinemia \\> 17mmol\u002Fl\n* Preoperative Extra Corporeal Membran Oxygenation (ECMO).\n* Preoperative mechanical ventilation",{"count":102,"type":21},80,"Complications after lung transplantation are almost ubiquitous, among which postoperative acute renal failure may represent more than 50% of lung transplant patients and require extrarenal purification in 5 to 13% of cases.\n\nMultiple factors are associated with postoperative acute renal failure. These factors can be classified into preoperative, intraoperative, and postoperative factors. While some postoperative complications are explained by donor and recipient factors, the literature suggests that certain intraoperative events represent modifiable or avoidable risk factors that could be targeted by therapeutic interventions to reduce the risk of postoperative acute renal failure. Some of these factors (intraoperative hemodynamic instability, significant bleeding or hypoxemia) can generate renal hypoxic aggression, alone or in combination. However, to date, there is no validated tool available at the patient's bedside during surgery to detect renal hypoxia or guide interventions to restore renal perfusion during surgery. Yet, as recent recommendations suggest, intraoperative renal protection is an important axis for improving the outcome of lung transplant patients, to the extent that the recommendations of Marczin et al. recommend the establishment of a renal prevention protocol for each patient. Without a tool to guide this plan intraoperatively, anesthesia teams can't establish a renal prevention protocol. This research aims to establish whether renal NIRS is a reliable tool for monitoring intraoperative renal hypoxic aggression predictive of postoperative renal failure.\n\nNear-infrared spectroscopy (NIRS) is an optical technology that allows non-invasive measurement of tissue oxygen saturation. This technique is commonly used for intraoperative monitoring of cerebral perfusion in adults and children. Some studies have shown that regional renal oxygen saturation (renal rSO2) measured by NIRS during aortic-coronary bypass surgery under extracorporeal circulation (ECC) is correlated with renal venous oxygen saturation measured by catheterization. It is also associated with the risk of postoperative acute renal failure in patients undergoing cardiac surgery under ECC. However, there are no equivalent data in lung transplant patients, who frequently present with postoperative acute renal failure. In the available literature, no clear threshold of renal desaturation has been established. Because it is assumed that the depth of renal desaturation can be particularly deleterious, in addition to desaturation time, the investigator have chosen to retain in this project the integral of time and magnitude spent under a renal desaturation threshold, aggregated into a renal hypoxia index, during the intraoperative period.\n\nThe primary objective of this research is to demonstrate the usefulness of measuring the intraoperative renal hypoxia index in predicting the risk of early postoperative acute renal failure",[27,105],"Acute Kidney Injury","2026-02-19",{"date":108,"type":32},"2026-02-23",{"date":110,"type":32},"2024-03-23",{"date":112,"type":21},"2026-09-28",{"name":114,"class":39},"Assistance Publique Hopitaux De Marseille",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":40},"100594297","inspiratory-work-of-breathing-before-and-after-extubation-100594297","NCT07017608","Inspiratory Work of Breathing Before and After Extubation","INTEGRATION","Inclusion Criteria:\n\n* Adult patients intubated and ventilated\n\nExclusion Criteria:\n\n* Contraindication for esophageal catheter insertion: upper gastrointestinal surgery within prior 6 weeks, actively bleeding esophageal varices\n* Bronchopleural fistula\n* Contraindication for electrical impedance tomography: chest burns, skin lesions in the thorax, chest wall bandaging limiting electrode placement, unstable spinal lesions or fractures\n* Pregnancy",{"count":123,"type":21},67,"Critically ill patients who (1) are not able to maintain their airway, (2) cannot breathe on their own, or (3) both, are ones who often require tracheal intubation and support from a breathing machine (mechanical ventilator). When the patient is ready to be liberated from the mechanical ventilator because the initial insult for intubation has been resolved, the patient is screened using the readiness to wean test in preparation for extubation. As the patient passes this screening, a spontaneous breathing test (SBT) is initiated. Currently, there are many debates surrounding which SBT technique is most favorable. At Toronto General Hospital, the clinical team uses a zero-end expiratory pressure (ZEEP) trial. Once the patient successfully passes their SBT they are then extubated.\n\nThe patient will undergo a spontaneous breathing trial of continuous positive airway pressure (CPAP) of 5 cmH2O and ZEEP, in which time the investigators will be using a new technology called electrical impedance tomography (EIT), to study and compare the end expiratory lung volume (EELV); investigators will use an esophageal catheter to measure and monitor pressures in the lung, and also assess the patient's work of breathing. This will be repeated once the patient has been extubated safely.",[27,126,127],"Ventilator-Induced Lung Injury","Ventilator Associated Pneumonia","2025-06-03",{"date":130,"type":32},"2025-06-12",{"date":132,"type":32},"2020-09-01",{"date":134,"type":21},"2026-12",{"name":136,"class":39},"University Health Network, Toronto",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":40},"100479743","cytokine-filtration-in-lung-transplantation-a-swedish-national-study-glusorb-100479743","NCT05526950","Cytokine Filtration in Lung Transplantation: A Swedish National Study (GLUSorb)","Cytokine Filtration in Lung Transplantation - a Randomised, Controlled, Multicentre Clinical Trial (GLUSorb)","Inclusion Criteria:\n\n• Eligibility to undergo double lung transplantation at either trial site\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. Previous organ transplantation\n3. Presence of any conditions at the time of surgery that require immunosuppressive therapy. Immunosuppressive therapy is defined as:\n\n   1. Cyclosporine, Tacrolimus, Everolimus, or Sirolimus, minimum 1 month of treatment prior to transplantation and active treatment at the time of transplantation.\n   2. Any form of antibody-based treatment that is known for having an immunomodulatory effect taken up to 1 week before transplantation.\n4. Non-consent","80 Years",{"count":146,"type":21},116,[148],"NA","Lung transplantation (LTx) remains the gold standard for treating patients with irreversible end-stage pulmonary disease. Of the major organs transplanted, survival in LTx recipients remains the lowest (mean 5 years). Despite improvements, primary graft dysfunction (PGD), as defined by respiratory insufficiency and edema up to 72 hours post LTx, remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) which is the leading cause of late mortality. PGD develops within the first 72 hours after LTx. The development of CLAD increases quickly with cumulative incidence of 40-80 % within the first 3-5 years. There is a general lack of efficient treatments for PGD and CLAD. Prevention of PGD is therefore of crucial importance and has a direct impact on survival.\n\nThe present study is a randomized controlled study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.",[83,27],"2023-09-14",{"date":153,"type":32},"2023-09-18",{"date":155,"type":32},"2023-09-07",{"date":157,"type":21},"2029-12-31",{"name":159,"class":39},"Lund University Hospital",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":167,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":40},"100426771","diagnostic-and-prognostic-biomarkers-of-transplant-dysfunction-in-the-context-of-lung-transplantation-100426771","NCT04837339","Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation","DATACOL","Inclusion Criteria:\n\n* Men or women over 15 years of age\n* Suffering from a lung condition requiring a transplant planned at Foch Hospital or being followed up at Foch Hospital following a lung transplant\n* Have signed the informed consent form and for patients aged 15 to 18 years that the person(s) exercising parental authority has\u002Fhave signed the informed consent.\n* Be affiliated with a Health Insurance plan.\n\nExclusion Criteria:\n\n* Pregnant, parturient and\u002For lactating woman\n* Hemoglobin level less than or equal to 8g\u002Fdl\n* Persons of full age who are subject to a legal protection measure or who are unable to express their consent\n* Persons under the protection of justice\n* Not being able to follow the study requirements for geographical, social or psychological reasons\n* Patient refusal.","15 Years",{"count":169,"type":21},900,[148],"Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation.\n\nEach dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample.",[82,83,27,173],"Lung Transplant Failure and Rejection",[165],"2022-08-02",{"date":177,"type":32},"2022-08-03",{"date":179,"type":32},"2022-03-17",{"date":181,"type":21},"2037-03",{"name":183,"class":39},"Hopital Foch"]