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The impact of body composition on peri-operative and patient-centered outcomes in lung transplantation.

身体成分对肺移植围手术期和以患者为中心的结果的影响。

基本信息

批准号：
10677598
负责人：
Jonathan Paul Singer
金额：
$ 42.71万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-05 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10677598
关键词：
Accounting Address Adoption Anxiety Area Biolectric Impedance Biological Assay Body Composition Body mass index Body measure procedure Cessation of life Clinical Clinical Research Clinical Trials Clinical Trials Design Cognitive Collaborations Data Development Dual-Energy X-Ray Absorptiometry Enrollment Evaluation Event Future Habilitation Health Hospitalization Individual Intervention Intervention Studies Intuition Investigation Knowledge Length of Stay Lung Transplantation Mental Depression Methods Modality Modeling Multicenter Studies Multicenter Trials National Heart, Lung, and Blood Institute Obesity Observational Study Outcome Outcome Measure Patient Outcomes Assessments Patient Selection Patient-Focused Outcomes Patients Perioperative Perioperative complication Phenotype Physical Function Postoperative Period Productivity Quality of life Reporting Risk Risk Factors Scanning Surveys Survivors Technology Time Transplant Recipients Transplantation Waiting Lists Work clinical care clinical practice cost disability experience frailty graft dysfunction graft failure graft function health related quality of life improved innovation mortality novel nutrition patient response physical conditioning post-transplant predictive modeling prognostic pulmonary function response sarcopenia sarcopenic obesity transplant centers

项目摘要

PROJECT ABSTRACT Lung transplantation aims to extend survival, relieve disability, and improve health-related quality of life (HRQL). Although many do well, perioperative complications have increased, one third of patients die within the first three post-transplant years and 20-40% of survivors do not report improvements in patient-reported outcomes (PROs) such as functioning and HRQL. Reasons for this lack of improvement are generally unknown. As a result, RFA- 022-002 highlights body composition and PROs as key priority areas for further investigation and intervention. In earlier work using BMI, CT scans, and DXA, our group showed that obesity and sarcopenia are prevalent in lung transplant candidates and are risk factors for frailty, primary graft dysfunction (PGD), and mortality. We also highlighted, the challenges to more widely implementing these modalities and introduced bioelectrical impedance (BIA) as a method of advanced body composition quantification that overcomes these challenges. We demonstrated that obesity and sarcopenia by BIA are risk factors for PGD, and wait-list death. Our preliminary data suggests that sarcopenic obesity may be a novel phenotype at heightened risk for perioperative complications. After transplant, PGD and other perioperative complications contribute to disability, poor HRQL, and death after transplant. Despite the clinical primacy of PROs, the only empirical data on the impact of perioperative complications on PROs comes from our single-center work. Data on which PROs are responsive to perioperative complications is lacking, hindering informed selection of PROs for use in future research. Finally, defining the factors and events from before through early after transplant that impact PROs can identify and prioritize targets for intervention and improve clinical trial efficiency through prognostic enrichment. To address these problems, we will enroll 803 lung transplant candidates and, in Aim 1, will define the impact of sarcopenic obesity, sarcopenia, and adiposity on peri-operative and PROs at 6-months. We hypothesize that sarcopenic obesity will confer heightened risk for perioperative complications, including PGD, even in patients with normal BMI. In Aim 2, we will define the responsiveness of PRO measures to PGD and other perioperative complications. Aim 2 will provide the foundational empirical data needed to inform appropriate PRO selection for future observational and interventional studies. Aim 3, will develop landmark prediction models accounting for pre-, peri- and early post-operative factors to identify groups with worse post-operative PROs at 6-months and time to graft failure up to 3-years after transplant. Developing new modeling of peri- and early post-operative outcomes to predict which individuals are at risk for poor outcomes will inform the prognostic enrichment strategies needed to improve clinical trial efficiency in lung transplant. In sum, we address key priorities in RFA HL-22-022 by examining body composition in an innovative and scalable manner; identifying high yield PROs for future studies and generating foundational knowledge to inform future studies and trials in lung transplantation.

项目摘要