NCT00834054

Brief Summary

Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

February 2, 2009

Last Update Submit

September 22, 2016

Conditions

MucoviscidosisPulmonary Insufficiency

Outcome Measures

Primary Outcomes (1)

  • extra-vascular lung water

    first postoperative days

Secondary Outcomes (1)

  • pulmonary permeability index

    first postoperative days

Study Arms (1)

Double-lung transplanted patients

Procedure: Double-lung transplantation

Interventions

Double-lung transplantationPROCEDURE

Double-lung transplanted patients

Double-lung transplanted patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

double-lung transplanted patients

You may qualify if:

  • double-lung transplanted patients

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Cystic FibrosisRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesRespiration Disorders

Study Officials

  • Charles Cerf, MD

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(1)