Live Lung Donor Cross-sectional Cohort Study

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT01524835

Collaborator

(none)

192

Enrollment

Locations

Duration (Months)

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Transplantation

Detailed 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

Study Type:

Observational

Actual Enrollment :

192 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Live Lung Donor Cross-sectional Cohort Study

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Live lung donors Live lung donors who participated in donation from 1993 through 2006

Outcome Measures

Primary Outcome Measures

Spirometric lung function [Measured at time of scheduled spirometry testing]

Secondary Outcome Measures

Quality of life [Throughout study]
Morbidity [Throughout study]
Psychosocial status, including anxiety and depression symptoms [Throughout study]
Satisfaction with live lung donation [Throughout study]
Decision-making associated with live lung donation [Throughout study]
Representativeness of participating live lung donor study sample [Throughout study]
Predictors of donor outcome and/or status [Throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Donated a lung at University of Southern California or Washington University between January 1, 1993 and December 31, 2006

Exclusion Criteria:

For questionnaire testing: inability to comprehend and complete questionnaires (with assistance)
For spirometry: self-reported pregnancy, inability to reproducibly perform, and contraindications
For post-bronchodilator spirometry: allergy to albuterol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033
2	Washington University School of Medicine	St. Louis	Missouri	United States	63110

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator: Mark Barr, MD, University of Southern California
Study Chair: Roger Yusen, MD, MPH, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT01524835

Other Study ID Numbers:

DAIT RELIVE-05

First Posted:

Feb 2, 2012

Last Update Posted:

Mar 27, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)

Study Results

No Results Posted as of Mar 27, 2017