Prognosis of Lung Transplant Candidates

Respiratory Failure Clinical Trial

Official title:

Analysis of Prognosis and Patient Reported Outcomes in Lung Transplant Candidates

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00905463
• Other study ID #: E554kyoto
• Status: Active, not recruiting
• Start date: April 2009
• Est. completion date: March 2022

Study information

• Verified date: August 2019
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 272
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• New lung transplant candidates

Exclusion Criteria:

• Heart and lung transplant candidates

• Uncontrolled severe comorbidities

Related Conditions & MeSH terms

• Lung Transplantation
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Lung transplantation
Lung transplantation

Locations

Country	Name	City	State
Japan	Graduate School of Medicine, Kyoto University	Kyoto
Japan	Okayama University	Okayama
Japan	Tohoku University	Sendai
Japan	Osaka University	Suita

Sponsors (2)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognosis/Mortality		5 years
Secondary	Health status		At entry and every year for 5 years
Secondary	Dyspnea		At entry and every year for 5 years
Secondary	Psychological status		At entry and every year for 5 years
Secondary	Sleep quality		At entry and every year for 5 years
Secondary	Pulmonary function		At entry and every year for 5 years
Secondary	Arterial blood gas		At entry and every year for 5 years