Clinical trial NCT01151826: Quantifying Physical and Biochemical Factors That Contribute to Primary Graft Dysfunction After Lung Transplantation
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 type: OBSERVATIONAL
Overall status: UNKNOWN
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)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung transplant recipients cared for in Surgical Intensive Care Unit in Strasbourg University Hospital, France

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.


Eligibility 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

Primary outcomes:
measure: Diagnosis and prognosis values of extravascular lung water (EVLW) and pulmonary vascular permeability index (PVPI).
timeFrame: H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation
Secondary outcomes:
measure: Diagnosis and prognosis values of receptor for advanced glycation endproducts (RAGE) and intercellular adhesion
timeFrame: H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation
Other outcomes:
Locations:
city: Strasbourg Cedex
country: France
facility: Service de Chirurgie thoracique - Nouvel Hôpital Civil - 1, Place de l'hôpital
city: Strasbourg Cedex
country: France
facility: Service de Physiologie et d'Explorations fonctionnelles - Nouvel Hôpital Civil - 1, Place de l'hôpital
city: Strasbourg Cedex
country: France
facility: Service de Pneumologie - Nouvel Hôpital Civil -1, Place de l'hôpital
city: Strasbourg
country: France
facility: Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg Strasbourg, France
name: Julien Pottecher, MD
role: STUDY_DIRECTOR
References:
citation: 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.