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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01151826
Other study ID # 4714
Secondary ID
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


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
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