Live Lung Donor Cross-sectional Cohort Study

Status Completed

Clinical Trial Summary

This study will gather information on the long-term effects of donating a lung lobe on living donors.

Clinical Trial Description

Over time, the number of patients on the lung transplant waiting list and the number of lung transplants performed have greatly increased. Unfortunately, the number of patients on the waiting list has outpaced the transplant rate, resulting in a significant number of deaths for patients on the waiting list.

Live lung donation has the potential to decrease wait time for lung transplants and the rate of death for those awaiting transplants. However, since live lung donation typically utilizes one lobe of lung from each of two donors, transplantation puts two donors at risk for adverse events. Although live lung donation began in the early 1990s, there is still a great lack of published and comprehensive, long-term studies, leaving the outcome of live lung donation unclear. This study will assess post-donation outcomes in live lung donors. Specifically, investigators will determine the effects of live lung donation on lung function, quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. Information obtained from this study will allow potential future live lung donors and the interested public to become better informed, and may also assist potential donors in their decision-making process regarding the procedure. Furthermore, positive study results could potentially reassure previous live organ donors about uncertainties concerning their future health.

There will be 369 participants recruited for this study based on live lung donations, which occurred from 1993 through 2006. Study coordinators will contact eligible participants inviting participants to the study and answering any questions. Participants will have the option to partially or completely refuse participation. Each consenting donor will complete a series of questionnaires via phone and mail. The questions address issues related to the donor's quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. The questionnaires will take about one hour to complete. The coordinator will offer assistance regarding questionnaire completion and return. At the end of the study, a final brief status update will be obtained via phone interview.

In addition to questionnaires, participants will also be asked to participate in spirometry testing. For consenting participants, spirometry testing will be scheduled at either the two study sites or an approved Pulmonary Function Laboratory. During the test, the participant will breathe in and out of a plastic tube while a machine measures the amount and flow of air the donor breathes in and out. If deemed appropriate, the participant will do this test again a few minutes after being given albuterol, a drug which aims to optimize lung function. Spirometry testing will last about an hour. ;

Study Design

Related Conditions & MeSH terms

Lung Transplantation

Clinical Trial Details

NCT number	NCT01524835
Study type	Observational
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	N/A
Start date	August 2010
Completion date	October 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02581111` - Naloxone for Optimizing Hypoxemia Of Lung Donors	Phase 2/Phase 3
Recruiting	`NCT02177916` - Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation	N/A
Not yet recruiting	`NCT01394835` - Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients	Phase 2
Completed	`NCT01204970` - Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients	N/A
Not yet recruiting	`NCT01162148` - Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation	N/A
Active, not recruiting	`NCT00980967` - Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study	N/A
Completed	`NCT00531921` - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival	N/A
Recruiting	`NCT00163696` - Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease	N/A
Completed	`NCT00177684` - Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)	Phase 3
Completed	`NCT00163891` - Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients	N/A
Completed	`NCT03668483` - Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx	N/A
Not yet recruiting	`NCT02855372` - Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)	N/A
Completed	`NCT01212406` - Vitamin D in Bronchiolitis Obliterans Syndrome	Phase 4
Completed	`NCT01211509` - Montelukast in Bronchiolitis Obliterans Syndrome	Phase 4
Not yet recruiting	`NCT00808600` - Empowerment of Lung and Heart-lung Transplant Patients	N/A
Completed	`NCT00553397` - Live Lung Donor Retrospective Study	N/A
Completed	`NCT00402805` - Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy	Phase 4
Completed	`NCT00701922` - Surveillance Study of Viral Infections Following Lung Transplantation	N/A
Terminated	`NCT00235651` - Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients	Phase 3
Active, not recruiting	`NCT02936505` - Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.	N/A