Quantifying Physical and Biochemical Factors That Contribute to Primary Graft Dysfunction After Lung Transplantation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Strasbourg, France.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Strasbourg, France
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01151826
First received: June 25, 2010
Last updated: March 1, 2011
Last verified: March 2011
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Purpose
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.
| Condition |
|---|
|
Primary Graft Dysfunction |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital, Strasbourg, France:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Lung transplant recipients cared for in Surgical Intensive Care Unit in Strasbourg University Hospital, France
Criteria
Inclusion Criteria:
- Lung transplant recipient
- Age > 18 years
- Signed informed consent
- Social security affiliation
Exclusion Criteria:
- Age<18
- Pregnancy or lactation
- Contraindication to femoral arterial catheterization
- Patient refusal
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01151826
Contacts
| Contact: Julien Pottecher, MD | 33 3 69 55 04 44 | julien.pottecher@chru-strasbourg.fr |
Locations
| France | |
| Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Julien Pottecher, MD 33 3 69 55 04 44 julien.pottecher@chru-strasbourg.fr | |
| Principal Investigator: Julien Pottecher, MD | |
| Sub-Investigator: Jean-Pierre DUPEYRON, MD | |
| Sub-Investigator: Olivier HELMS, MD | |
| Sub-Investigator: Jean-Gustave HENTZ, MD | |
| Sub-Investigator: François LEVY, MD | |
| Sub-Investigator: Jean-Claude RIGOLOT, MD | |
| Sub-Investigator: Anne-Claude ROCHE, MD | |
| Sub-Investigator: Régine CUNY, MD | |
| Sub-Investigator: Marie-Odile LEBOUBE, MD | |
| Service de Pneumologie - Nouvel Hôpital Civil -1, Place de l'hôpital | Recruiting |
| Strasbourg Cedex, France, 67091 | |
| Contact: Romain KESSLER, MD 33 3 69 55 06 45 Romain.Kessler@chru-strasbourg.fr | |
| Principal Investigator: Romain Kessler, MD | |
| Sub-Investigator: Armelle SCHULLER, MD | |
| Sub-Investigator: Matthieu CANUET, MD | |
| Sub-Investigator: Sandrine HIRSCHI, MD | |
| Service de Chirurgie thoracique - Nouvel Hôpital Civil - 1, Place de l'hôpital | Recruiting |
| Strasbourg Cedex, France, 67091 | |
| Contact: Gilbert MASSARD, MD 33 3 69 55 07 98 Gilbert.Massard@chru-strasbourg.fr | |
| Principal Investigator: Gilbert MASSARD, MD | |
| Sub-Investigator: Pierre-Emmanuel FALCOZ, MD | |
| Sub-Investigator: Nicola SANTELMO, MD | |
| Service de Physiologie et d'Explorations fonctionnelles - Nouvel Hôpital Civil - 1, Place de l'hôpital | Recruiting |
| Strasbourg Cedex, France, 67091 | |
| Contact: Bernard GENY, MD 33 3 69 55 08 79 Bernard.Geny@chru-strasbourg.fr | |
| Principal Investigator: Bernard GENY, MD | |
| Sub-Investigator: Anne CHARLOUX, MD | |
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
| Study Director: | Julien Pottecher, MD | Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg Strasbourg, France |
More Information
No publications provided
| Responsible Party: | Christine GEILLER, directeur de la Direction de la Recherche Clinique et des Innovations, University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT01151826 History of Changes |
| Other Study ID Numbers: | 4714 |
| Study First Received: | June 25, 2010 |
| Last Updated: | March 1, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Strasbourg, France:
|
Lung transplantation Primary Graft Dysfunction Extravascular Lung Water Receptor for Advanced Glycation Endproducts (RAGE) Intercellular Adhesion Molecule-1 (ICAM-1) |
Additional relevant MeSH terms:
|
Primary Graft Dysfunction Reperfusion Injury Vascular Diseases |
Cardiovascular Diseases Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013