Primary Graft DysfunctionNCT01151826
Quantifying Physical and Biochemical Factors That Contribute to Primary Graft Dysfunction After Lung Transplantation
An observational study of Primary Graft Dysfunction, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung transplantations and leads to severe early and late postoperative complications. Its pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased vascular permeability, pneumocyte dysfunction and finally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Graft Dysfunction
- How many people
- 45 participants
- Where
- 4 sitesFrance
- Study dates
- Jul 2010to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung transplant recipients cared for in Surgical Intensive Care Unit in Strasbourg University Hospital, France
Who may be able to join
- Lung transplant recipient
- Age > 18 years
- Signed informed consent
- Social security affiliation
Who cannot join
- Age<18
- Pregnancy or lactation
- Contraindication to femoral arterial catheterization
- Patient refusal
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Julien Pottecher, MD, 33 3 69 55 04 44, julien.pottecher@chru-strasbourg.fr
Julien Pottecher, MD
- Recruiting
Service de Chirurgie thoracique - Nouvel Hôpital Civil - 1, Place de l'hôpital
Strasbourg, 67091
Gilbert MASSARD, MD, 33 3 69 55 07 98, Gilbert.Massard@chru-strasbourg.fr
Gilbert MASSARD, MD
- Recruiting
Service de Physiologie et d'Explorations fonctionnelles - Nouvel Hôpital Civil - 1, Place de l'hôpital
Strasbourg, 67091
Bernard GENY, MD, 33 3 69 55 08 79, Bernard.Geny@chru-strasbourg.fr
Bernard GENY, MD
- Recruiting
Service de Pneumologie - Nouvel Hôpital Civil -1, Place de l'hôpital
Strasbourg, 67091
Romain KESSLER, MD, 33 3 69 55 06 45, Romain.Kessler@chru-strasbourg.fr
Romain Kessler, MD
About this study
Official title: Measurement of Physical and Biochemical Markers of Reperfusion Edema During Primary Graft Dysfunction Following Lung Transplantation. Assessment of Their Diagnosis and Prognosis Values
Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung transplantations and leads to severe early and late postoperative complications. Its pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas exchange and blood oxygenation.Its substrate, namely extravascular lung water (EVLW), can now be clinically measured with minimally invasive Intensive Care Unit monitors (PiCCO2®, Pulsion Medical Systems) that also provides a physical estimate of pulmonary vascular permeability (PVPI). Similarly, biochemical correlates of vascular permeability (ICAM-1) and pneumocyte dysfunction (RAGE) can now be measured in plasma samples. Our study aims at quantifying physical and biochemical markers of PGD and assess their diagnosis and prognosis values.
- Conditions
- Primary Graft Dysfunction
- Keywords
- Lung transplantation, Primary Graft Dysfunction, Extravascular Lung Water, Receptor for Advanced Glycation Endproducts (RAGE), Intercellular Adhesion Molecule-1 (ICAM-1)
- Medical subject headings
- Primary Graft Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis and prognosis values of extravascular lung water (EVLW) and pulmonary vascular permeability index (PVPI).
Measured: H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation
Secondary outcomes (1)
Diagnosis and prognosis values of receptor for advanced glycation endproducts (RAGE) and intercellular adhesion
Measured: H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Graft DysfunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Julien Pottecher, MD, Study director, Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151826
- Sponsor's protocol ID
- 4714
- Status last verified
- Mar 2011
- First submitted
- 25 Jun 2010
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pottecher J, Roche AC, Degot T, Helms O, Hentz JG, Schmitt JP, Falcoz PE, Santelmo N, Levy F, Collange O, Uring-Lambert B, Bahram S, Schaeffer M, Meyer N, Geny B, Lassalle P, Diemunsch P, Massard G, Kessler R, Steib A; Groupe de Transplantation Pulmonaire des Hopitaux Universitaires de Strasbourg. Increased Extravascular Lung Water and Plasma Biomarkers of Acute Lung Injury Precede Oxygenation Impairment in Primary Graft Dysfunction After Lung Transplantation. Transplantation. 2017 Jan;101(1):112-121. doi: 10.1097/TP.0000000000001434.
PubMed 27495752
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Physical and Biochemical Markers of Reperfusion Edema During Primary Graft Dysfunction Following Lung Transplantation. Assessment of Their Diagnosis and Prognosis Values
- ClinicalTrials.gov ID
- NCT01151826
- Acronym / sponsor ID
- 4714
- Conditions
- Primary Graft Dysfunction
- Keywords
- Lung transplantation, Primary Graft Dysfunction, Extravascular Lung Water, Receptor for Advanced Glycation Endproducts (RAGE), Intercellular Adhesion Molecule-1 (ICAM-1)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 28 Jun 2010 (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.
Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung transplantations and leads to severe early and late postoperative complications. Its pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas exchange and blood oxygenation.Its substrate, namely extravascular lung water (EVLW), can now be clinically measured with minimally invasive Intensive Care Unit monitors (PiCCO2®, Pulsion Medical Systems) that also provides a physical estimate of pulmonary vascular permeability (PVPI). Similarly, biochemical correlates of vascular permeability (ICAM-1) and pneumocyte dysfunction (RAGE) can now be measured in plasma samples. Our study aims at quantifying physical and biochemical markers of PGD and assess their diagnosis and prognosis values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant recipients cared for in Surgical Intensive Care Unit in Strasbourg University Hospital, France
Key inclusion criteria (4 listed)
- Lung transplant recipient
- Age > 18 years
- Signed informed consent
- Social security affiliation
Key exclusion criteria (4 listed)
- Age<18
- Pregnancy or lactation
- Contraindication to femoral arterial catheterization
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis and prognosis values of extravascular lung water (EVLW) and pulmonary vascular permeability index (PVPI).
Time frame: H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation
1 secondary outcome
Diagnosis and prognosis values of receptor for advanced glycation endproducts (RAGE) and intercellular adhesion
Time frame: H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
- Derived from this study: PubMed 27495752Pottecher J, Roche AC, Degot T, Helms O, Hentz JG, Schmitt JP, Falcoz PE, Santelmo N, Levy F, Collange O, Uring-Lambert B, Bahram S, Schaeffer M, Meyer N, Geny B, Lassalle P, Diemunsch P, Massard G, Kessler R, Steib A; Groupe de Transplantation Pulmonaire des Hopitaux Universitaires de Strasbourg. Increased Extravascular Lung Water and Plasma Biomarkers of Acute Lung Injury Precede Oxygenation Impairment in Primary Graft Dysfunction After Lung Transplantation. Transplantation. 2017 Jan;101(1):112-121. doi: 10.1097/TP.0000000000001434.
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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.
Julien Pottecher, MD study director
Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg Strasbourg, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Graft Dysfunction, run by University Hospital, Strasbourg, France at 4 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Pottecher, MD (33 3 69 55 04 44, julien.pottecher@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis and prognosis values of extravascular lung water (EVLW) and pulmonary vascular permeability index (PVPI). (time frame: H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01151826, which also lists 1 linked publication.
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 2 Mar 2011.