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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01151826
First received: June 25, 2010
Last updated: March 1, 2011
Last verified: March 2011
History of Changes

June 25, 2010
March 1, 2011
July 2010
August 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01151826 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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Quantifying Physical and Biochemical Factors That Contribute to Primary Graft Dysfunction After Lung Transplantation
Measurement of Physical and Biochemical Markers of Reperfusion Edema During Primary Graft Dysfunction Following Lung Transplantation. Assessment of Their Diagnosis and Prognosis Values

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Lung transplant recipients cared for in Surgical Intensive Care Unit in Strasbourg University Hospital, France
Primary Graft Dysfunction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Julien Pottecher, MD 33 3 69 55 04 44 julien.pottecher@chru-strasbourg.fr
France
 
NCT01151826
4714
No
Christine GEILLER, directeur de la Direction de la Recherche Clinique et des Innovations, University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Study Director: Julien Pottecher, MD Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg Strasbourg, France
University Hospital, Strasbourg, France
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP