View clinical trials related to Lung Transplant.
Filter by:The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list.
In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality. After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU. Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity. In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies.
Proning manoeuvre as an early treatment for acute severe hypoxic respiratory failure has been implemented recently during the COVID-19 pandemic. This method was proposed more than fifty years ago to improve gas exchange : Proning Severe ARDS (PROSEVA) trial, however, was the milestone which demonstrated mortality benefit in patients with severe ARDS. Nevertheless, few analysis were performed on the effects of the prone position after lung transplantion (LT). The aim of the study is therefore to relate LT primary graft dysfunction (PGD) pathophysiology, which occurs in postoperative setting, to prone-positioning effects on ventilation-perfusion matching, improved lung compliance and clinical outcomes of impairedorgan patients.
The primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation. Transesophageal echocardiography (TEE) (creates pictures of the heart from inside the participants body) is routinely performed for all lung transplantations at the University of California, Los Angeles (UCLA) and it is the standard of care. Patients are randomized to two groups. The intervention group would limit the number of TEE clips (# pictures taken) per case. The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist. The investigators hypothesize that reduction in TEE imaging during lung transplantation will reduce dysphagia.
Lung transplantation (LT) is the treatment for end-stage respiratory failure, for severe cases after thorough clinical and paraclinical evaluation. Patients often face a lengthy journey before being placed on the transplant list, and post-transplant care can seem to be demanding. Patient-Important Outcomes (PIO), have emerged across various medical fields, aiming to prioritize the patient's perspective in medical research. This approach seeks to align clinical outcomes with those important to patients, such as pain, mobility, autonomy, and quality of life. The focus on patient-centered research is crucial not only in medical care but also in clinical research. While several medical fields have embraced this approach, including diabetology, rheumatology, urology, and more, the field of lung transplantation has yet to fully explore the importance of PIO. LT addresses diverse underlying conditions (e.g., cystic fibrosis, pulmonary fibrosis, emphysema, pulmonary hypertension), impacting potentially different patient populations. However, the transplantation process standardizes certain aspects, such as follow-up obligations, treatments, side effects, and complications, which can affect patient quality of life. A systematic literature review of LT studies published in 2019 found that only 11 out of 51 studies evaluated PIOs beyond mortality. This highlights the need to assess interventions in this field based on criteria important to patients. Besides the impact on the patient, the influence on their close family members and caregivers is significant. The transition from severe respiratory disease to near-normal respiratory function can lead to a reevaluation of the caregiver's role and responsibilities. Currently, researchers and clinicians in transplantation focus more on Patient-Reported Outcomes (PRO) than on outcomes important to patients. To bridge this gap, this study aims to identify PIOs from the perspectives of clinicians, transplant recipients, and their families. The Delphi method is chosen to gather anonymous expert opinions and reach a consensus on defining PIOs in the context of lung transplantation. Ultimately, this research aims to create a "core outcome set" necessary for LT research, incorporating dimensions beyond mortality, which is the traditional focus in assessing transplant outcomes.
This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) listed for re-transplantation, and c) death
The purpose of this research study is to see if participating in Latin dance for 12 sessions can improve wellbeing in several areas including balance, fear of movement, anxiety, depression and spirometry.
Despite lung transplantation (LTx) being the most effective treatment for end-stage lung disease, its success rate is lower than that of other solid organ transplantations. Primary graft dysfunction (PGD) is the most common post-operative complication and a major factor in early mortality and morbidity, affecting ~25% of lung transplant patients. Induced by ischemia reperfusion, PGD represents a severe and acute lung injury that occurs within the first 72 hours after transplantation, and has a significant impact on short- and long-term outcomes, and a significant increase in treatment costs. Any intervention that reduces the risk of PGD will lead to major improvements in short- and long-term transplant outcomes and health care systems. One of the main strategies to reduce the risk and severity of post-transplant PGD is to improve pre-transplant donor lung preservation methods. In current practice, lung preservation is typically performed by cold flushing the organ with a specialized preservation solution, followed by subsequent hypothermic storage on ice (~4°C). This method continues to be used and applied across different organ systems due to its simplicity and low cost. Using this method for the preservation of donor lungs, the current maximum accepted preservation times have been limited to approximately 6-8h. While the goal of hypothermic storage is to sustain cellular viability during ischemic time through reduced cellular metabolism, lower organ temperature has also been shown to progressively favor mitochondrial dysfunction. Therefore, the ideal temperature for donor organ preservation remains to be defined and should maintain a balance between avoidance of mitochondrial dysfunction and prevention of cellular exhaustion. In addition to that, safe and longer preservation times can lead to multiple advantages such as moving overnight transplants to daytime, more flexibility to transplant logistics, more time for proper donor to recipient matching etc. Building on pre-clinical research suggesting that 10°C may be the optimal lung storage temperature, a prospective, multi-center, non-randomized clinical trial was conducted at University Health Network, Medical University of Vienna and Puerta de Hierro Majadahonda University Hospital. Donor lungs meeting criteria for direct transplantation and with cross clamp times between 6:00pm - 4:00am were intentionally delayed to an earliest allowed start time of 6:00am and a maximum preservation time from donor cold flush to recipient anesthesia start time of 12 hours. Lungs were retrieved and transported in the usual fashion using a cooler with ice and transferred to a 10°C temperature-controlled cooler upon arrival to transplant hospital until implantation. The primary outcome of this study was incidence of Primary Graft Dysfunction (PGD) Grade 3 at 72h, with secondary endpoints including: recipient time on the ventilator, ICU Length of Stay (LOS), hospital LOS, 30-day survival and lung function at 1-year. Outcomes were compared to a contemporaneous conventionally transplanted recipient cohort using propensity score matching at a 1:2 ratio. 70 patients were included in the study arm. Post-transplant outcomes were comparable between the two groups for up to 1 year. Thus, intentional prolongation of donor lung preservation at 10°C was shown to be clinically safe and feasible. In the current study design, the investigators will conduct a multi-centre, non-inferiority, randomized, controlled trial of 300 participants to compare donor lung preservation from the time of explant to implant at ~10°C in X°Port Lung Transport Device (Traferox Technologies Inc.) vs a standard ice cooler. When eligible donor lungs become available for a consented recipient, the lungs will be randomized to undergo a preservation protocol using either 10°C (X°Port Lung Transport Device, Traferox Technologies Inc.) or standard of care. The primary outcome of the study is incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours. Post-transplant outcomes will be followed for one year.
Patients enlisted for bilateral lung transplantation (LUTX) have subclinical right ventricle (RV) dysfunction1, which is usually clinically silent until LUTX. During LUTX, several reasons (i.e., sequential pulmonary arteries cross-clamp, hypoxia, hypercapnia) lead to de-compensation of RV function, cardiac failure and shock2. In this clinical scenario, extracorporeal life support (ECLS) with cardiopulmonary bypass (CBP) or extracorporeal membrane oxygenation (ECMO) is emergently implemented. ECLS is associated with prolonged mechanical ventilation, primary graft dysfunction (PGD), bleeding, and graft rejection3. This may be due to: 1) the activation of pro-inflammatory cascade due to blood-circuit contact; 2) the increased need for allogenic blood components, which per se has been associated to an increased risk of PGD4. Avoiding intraoperative ECLS may thus have significant positive clinical outcomes. In the general cohort of patients undergoing LUTX, pulmonary hypertension, and right ventricular dysfunction have been identified as risk factors for intraoperative ECLS5. At enlistment for LUTX, patients undergo a comprehensive evaluation of right cardiac function comprising: transthoracic echocardiography, pulmonary artery catheterization, and calculation of RV ejection fraction (RVEF) by multiple gated radionuclide ventriculography. Echocardiography is non-invasive, can be performed repeatedly and at the bedside. The free-wall RV longitudinal strain (RVLS) is a novel echocardiographic method for quantification of myocardial deformation6 with high diagnostic accuracy to predict depressed RV ejection fraction. RVLS may be used for non-invasive, repeated and bedside assessment of RV function before LUTX. We envision the employment of RVLS to document subclinical RV dysfunction before LUTX.
This is a prospective observational registration trial for patients who undergo lung transplantation for the treatment of the select groups of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis.