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Lung Transplant; Complications clinical trials

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NCT ID: NCT04687475 Recruiting - Cystic Fibrosis Clinical Trials

Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

Start date: April 20, 2020
Phase: N/A
Study type: Interventional

Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

NCT ID: NCT04522388 Enrolling by invitation - Clinical trials for Lung Transplant; Complications

Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

This non-randomized pilot study aims to investigate whether a protein rich nutritional shake (Ensure Enlive) given to patients pre-transplant will decrease skeletal muscle loss (measured by quadriceps ultrasound) and improve nutritional state (measured by Nutritional Risk Index). A nutritional supplement would be a cost-effective solution to treat malnutrition, a known risk factor implicated in poor outcomes for lung transplant recipients.

NCT ID: NCT04505878 Withdrawn - Clinical trials for Lung Transplant; Complications

Perioperative Vitamin C Lung Transplant

Start date: April 2023
Phase: Phase 2
Study type: Interventional

This study is being done to determine if parenterally administered ascorbic acid (Vitamin C) given at the time of lung transplant is safe. Vitamin C may be an effective intervention towards primary graft dysfunction (PGD). The study will enroll 69 participants who consent to the intervention. Participants who do not consent to the intervention will be treated according to standard-of-care, but may choose to be consented to have their data retrospectively reviewed. Based on our consent rate, this group may include 40-70 participants. Participants will be on study for up to 12 months.

NCT ID: NCT04469842 Enrolling by invitation - Clinical trials for Lung Transplant; Complications

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

Start date: December 1, 2023
Phase: Early Phase 1
Study type: Interventional

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/or 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. Long-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/dose 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.

NCT ID: NCT04377139 Not yet recruiting - Clinical trials for Lung Transplant; Complications

Management of Cytomegalovirus (CMV) Infection in Lung Transplant Recipients (LTR)

Start date: June 2020
Phase:
Study type: Observational

Background: Lung transplant recipients (LTR) have the highest risk of CMV infection. CMV pneumonitis, lymphocytic bronchitis, and detection of CMV DNA in bronchoalveolar lavage fluid are independent risk factors for the development of chronic lung allograft dysfunction (CLAD). However, to demonstrate the clinical impact of the indirect effects of CMV, it is necessary to conduct studies with a very large sample size. Hypothesis: The different current preventive strategies for CMV infection in LTR and their clinical application on a daily basis impact on the development of direct and indirect effects of CMV in this population. Objectives: To study the effect of CMV infection on LTR in relation to current preventive strategies in terms of: - The incidence of acute and chronic rejection - The incidence of other opportunistic infections - The incidence of neoplastic disease, especially, post-transplant lymphoproliferative disease - Patient and graft survival Methods: Multicenter, retrospective, cohort study. Consecutive inclusion of all adult lung transplant recipients from 2013 to 2017 with 2 years of follow-up. The investigators will collect and analyze the main clinical and microbiological variables in order to respond to the objectives of the study. Relevance: Knowing in detail the current epidemiology of CMV infection in LTR and its subsequent influence on both mortality and the presence of different complications, could allow improving the management of these patients in the future.

NCT ID: NCT04165161 Completed - Clinical trials for Lung Transplant; Complications

Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography

FOP-TP
Start date: October 30, 2019
Phase: N/A
Study type: Interventional

The investigators hypothesis is that an injection into the inferior vena cava associated with a provocation maneuver should allow to increase the incidence of FOP found by transesophageal echocardiography in a population of patients undergoing lung transplantation.

NCT ID: NCT03792698 Completed - Clinical trials for Lung Transplant; Complications

Preventing Rehospitalization in Lung Transplant Recipients Utilizing mHealth

PERSPIRE
Start date: January 15, 2019
Phase: N/A
Study type: Interventional

Lung transplantation has several important aims: 1) extend survival; 2) relieve disability, and 3) improve health-related quality of life (HRQL) for adults suffering from end-stage lung disease. Advances in medical therapies and changes in the US organ allocation system in 2005 have prioritized lung transplant for sicker and older patients. This achievement has come at substantial cost, including recent trends in recipients towards increased disability, poorer health-related quality of life, and increased longer-term mortality. Additionally, lung transplant recipients have the highest risk of unexpected readmission after the index admission, with published rates of 40-43%. Frailty at the time of discharge is one of the leading factors for readmission. The investigator's belief is that improving access to individualized exercise training plans that are modified based on a patient's progress and needs will greatly improve a transplant recipient's level of physical fitness and independence, and decrease the risk of hospital readmission. This will lead to an overall improvement in a patient's quality of life.

NCT ID: NCT03767049 Completed - Clinical trials for Lung Transplant; Complications

Readmissions of Lung Transplant Patients in ICU.

Start date: August 1, 2012
Phase:
Study type: Observational

A multi-centre, prospective and observational study was carried out from August 2012 to June 2016 in five Spanish tertiary-care university hospitals with well-established lung transplant programs: Vall d'Hebron (Barcelona), Marqués de Valdecilla (Santander), 12 de Octubre (Madrid), CHUAC (A Coruña), and Reina Sofía (Córdoba). The study population comprised all consecutive adult lung transplant recipients who required ICUr (after >7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr period).

NCT ID: NCT03657342 Active, not recruiting - Clinical trials for Bronchiolitis Obliterans

Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)

BOSTON-1
Start date: April 2, 2019
Phase: Phase 3
Study type: Interventional

The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in single lung transplant recipients.

NCT ID: NCT03657004 Completed - Clinical trials for Chronic Kidney Diseases

Immunosuppressive Regimen on Changes in Renal Function and Transplant Rejection Rate in Patients With Lung Transplant

Start date: August 29, 2018
Phase:
Study type: Observational

This retrospective single-center analyzes the impact of switch of immunosuppressive regimen on renal function and transplant rejection rate in patients with lung transplant.