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Lung Transplant; Complications clinical trials

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NCT ID: NCT05242289 Completed - Clinical trials for Lung Transplant; Complications

Cytokine Adsorption in Lung Transplantation

Start date: March 2, 2022
Phase: N/A
Study type: Interventional

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 (2). 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. The present study is a randomized controlled pilot study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.

NCT ID: NCT05116748 Completed - COVID-19 Clinical Trials

COVID19 Vaccine in SOT Adult Recipients

COVID19_VaxSOT
Start date: October 1, 2021
Phase:
Study type: Observational

Background: ISHLT and AASLD guidelines recommend SARS-CoV2 vaccination in all individuals undergoing lung and liver transplantation, but there are currently scarce data on the safety and efficacy of these vaccines in this population. In Italy, immunocompromised patients have received the indication to be administered mRNA vaccines only. Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19 Visits and timepoints: - T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status - Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination - T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity - Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

NCT ID: NCT05081141 Recruiting - Clinical trials for Kidney Transplant; Complications

HHV8 and Solid Organ Transplantation

Start date: September 15, 2021
Phase:
Study type: Observational

Solid organ transplant candidates will undergo serological screening for HHV8 at time of listing and transplantation. In the event of a recipient/donor mismatch R-/D+ or in the presence of a seropositive recipient (R+), blood levels of HHV8 DNA will be monitored together with specific IGRA for HHV8.

NCT ID: NCT05050955 Recruiting - Clinical trials for Lung Transplant; Complications

AlloSure Lung Assessment and Metagenomics Outcomes Study

ALAMO
Start date: October 29, 2021
Phase:
Study type: Observational [Patient Registry]

ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap for surveillance post-transplant. This study aims to investigate the clinical utility of AlloSure®-Lung for surveillance of the spectrum of rejection and infection events in concert with standard of practice (SOP) post-transplant medical care in a robust lung transplant population. The AlloID™ metagenomics NGS plasma test will be collected and performed for research to validate this molecular diagnostic tool versus SOP microbiologic techniques for detection of allograft infection events.

NCT ID: NCT05001074 Recruiting - Clinical trials for Lung Transplant; Complications

Trial Comparing Immediate Versus Extended Release Tacrolimus; Reducing Calcineurin Inhibitor Related Toxicity in Lung Transplantation Patients

REVOLUTION
Start date: July 28, 2020
Phase: Phase 3
Study type: Interventional

Lung transplantation is a life-saving option in patients with end-stage lung disease. The introduction of calcineurin inhibitors has significantly improved long-term outcome in lung transplantation. The most frequently used calcineurin inhibitor as maintenance therapy is immediate release tacrolimus, dosed twice daily, which has shown to reduce both acute and chronic rejection. However, a drawback to the administration of tacrolimus is its toxicity. Especially progressive renal toxicity, new onset diabetes and hypertension contribute to the high cardiovascular burdon in this patient group. Since a few years an once daily extended release tacrolimus has been introduced in solid organ transplantation. The advantage of extended release tacrolimus is its prolonged release and higher bioavailability than other tacrolimus formulations. This result in lower peaks, more stable serum levels over 24 hours, and less fluctuation of blood concentrations. Long-term toxicity outcome of extended release tacrolimus after lung transplantation has not been studied so far. Therefore the potential benefit of exteded release tacrolimus in de novo and stable post-lung transplant recipients should be investigated.

NCT ID: NCT04975607 Active, not recruiting - Clinical trials for Lung Transplant; Complications

Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: A Pilot Study

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective pilot study is to determine if live music therapy reduces patients' perception of pain and anxiety, reduces benzodiazepine use and pain medication use, length of stay in the ICU, and length of stay in hospital, and improves sleep in post-lung transplant patients. The purpose and objectives of the study are the following: - To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived anxiety in post-lung transplant patients. - To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived pain in post-lung transplant patients. - To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's use of benzodiazepine medication for anxiety. - To determine if music therapist delivered patient preferred live music and therapeutic intervention three times in post-lung transplant patients will reduce participant's use of pain medication. - To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's total time of intubation, length of stay in ICU, and length of stay in the hospital. - To determine if music therapist delivered patient preferred live music and therapeutic intervention will improve the quality and length of sleep in post-lung transplant patients.

NCT ID: NCT04892719 Completed - Clinical trials for Lung Transplant; Complications

4DX Functional Lung Imaging in the Diagnosis of Chronic Lung Allograft Dysfunction After Lung Transplantation

Start date: October 28, 2020
Phase: N/A
Study type: Interventional

This is a pilot study to determine the utility of Novel Functional Lung Imaging and Ventilation (4DxV) Analysis software in measurement of lung ventilation abnormalities and diagnosis of chronic lung allograft dysfunction (CLAD) after lung transplantation.

NCT ID: NCT04837339 Recruiting - Clinical trials for Lung Transplant Rejection

Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation

DATACOL
Start date: March 17, 2022
Phase: N/A
Study type: Interventional

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. Each 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.

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.