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

• Conditions: Primary Graft Dysfunction

• Registration Number: NCT01151826
• Lead Sponsor: University Hospital, Strasbourg, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Study Start: 2010-07
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-01
• Last Update Posted: 2011-03-02
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis and prognosis values of extravascular lung water (EVLW) and pulmonary vascular permeability index (PVPI).	H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation

Secondary Outcome Measures

Name	Time	Method
Diagnosis and prognosis values of receptor for advanced glycation endproducts (RAGE) and intercellular adhesion	H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation

Trial Locations

Locations (4)

Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Service de Pneumologie - Nouvel Hôpital Civil -1, Place de l'hôpital; 🇫🇷 Strasbourg Cedex, France

Service de Chirurgie thoracique - Nouvel Hôpital Civil - 1, Place de l'hôpital; 🇫🇷 Strasbourg Cedex, France

Service de Physiologie et d'Explorations fonctionnelles - Nouvel Hôpital Civil - 1, Place de l'hôpital; 🇫🇷 Strasbourg Cedex, France