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

Primary Graft Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01151826
• Other study ID #: 4714
• Status: Recruiting
• Phase: N/A
• First received: June 25, 2010
• Last updated: March 1, 2011
• Start date: July 2010
• Est. completion date: August 2012

Study information

• Verified date: March 2011
• Source: University Hospital, Strasbourg, France
• Contact: Julien Pottecher, MD
• Phone: 33 3 69 55 04 44
• Email: julien.pottecher[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Primary Graft Dysfunction

Locations

Country	Name	City	State
France	Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg	Strasbourg
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	Service de Pneumologie - Nouvel Hôpital Civil -1, Place de l'hôpital	Strasbourg Cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No