Prognosis of Lung Transplant Candidates

• Conditions: Respiratory Failure; Lung Transplantation
• Interventions: Procedure: Lung transplantation

• Registration Number: NCT00905463
• Lead Sponsor: Kyoto University, Graduate School of Medicine

Brief Summary

The purposes of the study are (1) to analyze the baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine the longitudinal clinical course in the lung transplant candidates in Japan.

Detailed Description

The significance of assessing patient reported measurements including health status, dyspnea and psychological status has not been well investigated in the lung transplant candidates. Therefore, in the present study, we aim to examine (1) contributive factors to their health status based on baseline data, (2) whether patient reported measurements would predict patients' prognosis and (3) how they would change for 5 years as compared to physiological measurements.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-25
• Last Update Posted: 2019-08-28
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• New lung transplant candidates

Exclusion Criteria

• Heart and lung transplant candidates
• Uncontrolled severe comorbidities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transplantation	Lung transplantation	Lung transplantation candidates

Primary Outcome Measures

Name	Time	Method
Prognosis/Mortality	5 years

Secondary Outcome Measures

Name	Time	Method
Arterial blood gas	At entry and every year for 5 years
Health status	At entry and every year for 5 years
Dyspnea	At entry and every year for 5 years
Psychological status	At entry and every year for 5 years
Sleep quality	At entry and every year for 5 years
Pulmonary function	At entry and every year for 5 years

Trial Locations

Locations (4)

Okayama University; 🇯🇵 Okayama, Japan

Osaka University; 🇯🇵 Suita, Japan

Tohoku University; 🇯🇵 Sendai, Japan

Graduate School of Medicine, Kyoto University; 🇯🇵 Kyoto, Japan