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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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         
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
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Reperfusion Injury
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014