Patient Reported Outcomes in Living Donor Lung Transplantation

August 27, 2019 updated by: Toru Oga, Kyoto University, Graduate School of Medicine

Analysis of Patient Reported Outcomes in Living Donor Lung Transplantation

The purpose of the present study is to investigate how the health of donors in living donor lung transplantation will change after transplant operations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In Japan, living donor lung transplantation has been established as an alternative therapy for brain-dead lung transplantation, as the number of organs for transplantation is absolutely short. However, how patient reported measurements including health status, dyspnea, psychological status and sleep would change after lung transplantation has not been well evaluated. Therefore, in the present study, we aim (1) to compare them before and after transplant operations and (2) to analyze how they will change for 5 years.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan
        • Graduate School of Medicine, Kyoto University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Kyoto University Hospital Clinic for Lung Transplantation

Description

Inclusion Criteria:

  • New donors for living donor lung transplantation

Exclusion Criteria:

  • Inability to obtain informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Living donor lung transplantation
Living lung transplantation donors
Procedure: Living donor lung transplantation
Living donor lung transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in health status
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in dyspnea
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years
Change in psychological status
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years
Change in sleep quality
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years
Prognosis
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Hiroshi Date, MD, PhD, Graduate School of Medicine, Kyoto University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E561kyoto

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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