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

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

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

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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):

Pottecher J, Roche AC, Dégot 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 Hôpitaux 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.

• Responsible Party: Christine GEILLER, directeur de la Direction de la Recherche Clinique et des Innovations, University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT01151826
• Other Study ID Numbers: 4714
• First Posted: June 28, 2010
• 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