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Quantifying Physical and Biochemical Factors That Contribute to Primary Graft Dysfunction After Lung Transplantation

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ClinicalTrials.gov Identifier: NCT01151826
Recruitment Status : Unknown
Verified March 2011 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : June 28, 2010
Last Update Posted : March 2, 2011
Sponsor:
Information provided by:

Study Description
Brief 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 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 or disease
Primary Graft Dysfunction

Study Design

Study Type : Observational
Estimated Enrollment : 45 participants
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
Study Start Date : July 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151826


Contacts
Contact: Julien Pottecher, MD 33 3 69 55 04 44 julien.pottecher@chru-strasbourg.fr

Locations
France
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         
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 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         
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: June 28, 2010    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: March 2011

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