MucoviscidosisPICCO-LungTNCT00834054
Measurement of Lung Water by Transpulmonary Thermodilution in Lung Transplanted Patients
An observational study of Mucoviscidosis and Pulmonary Insufficiency, run by Hopital Foch at 1 site in France.
Trial summary
Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mucoviscidosis, Pulmonary Insufficiency
- What is being tested?
- Double-lung transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: double-lung transplanted patients
Who may be able to join
- double-lung transplanted patients
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Repeated Extravascular Lung Water Measurements With the PICCO Device in Lung Transplanted Patients
Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation
- Conditions
- Mucoviscidosis, Pulmonary Insufficiency
- Being tested
- Double-lung transplantation
- Medical subject headings
- Cystic Fibrosis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-lung transplantationProcedure or surgery
Double-lung transplanted patients
| Study group | Role | What they receive |
|---|---|---|
| Double-lung transplanted patients | Not described Receives: Procedure: Double-lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
extra-vascular lung water
Measured: first postoperative days
Secondary outcomes (1)
pulmonary permeability index
Measured: first postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucoviscidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Cerf, MD, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834054
- Sponsor's protocol ID
- 2008/18
- Acronym
- PICCO-LungT
- Status last verified
- Sep 2016
- First submitted
- 2 Feb 2009
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Repeated Extravascular Lung Water Measurements With the PICCO Device in Lung Transplanted Patients
- ClinicalTrials.gov ID
- NCT00834054
- Acronym / sponsor ID
- PICCO-LungT / 2008/18
- Conditions
- Mucoviscidosis, Pulmonary Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double-lung transplanted patients | – | Procedure: Double-lung transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- double-lung transplanted patients
Key inclusion criteria (1 listed)
- double-lung transplanted patients
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double-lung transplantationDouble-lung transplanted patients | Procedure or surgery | Double-lung transplanted patients |
Primary outcome
extra-vascular lung water
Time frame: first postoperative days
1 secondary outcome
pulmonary permeability index
Time frame: first postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Cerf, MD study chair
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucoviscidosis and Pulmonary Insufficiency, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extra-vascular lung water (time frame: first postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.