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

March 1, 2011 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Julien POTTECHER, MD
        • Sub-Investigator:
          • Jean-Pierre DUPEYRON, MD
        • Sub-Investigator:
          • Olivier HELMS, MD
        • Sub-Investigator:
          • Jean-Gustave HENTZ, MD
        • Sub-Investigator:
          • François LEVY, MD
        • Sub-Investigator:
          • Jean-Claude RIGOLOT, MD
        • Sub-Investigator:
          • Anne-Claude ROCHE, MD
        • Sub-Investigator:
          • Régine CUNY, MD
        • Sub-Investigator:
          • Marie-Odile LEBOUBE, MD
      • Strasbourg Cedex, France, 67091
        • Recruiting
        • Service de Chirurgie thoracique - Nouvel Hôpital Civil - 1, Place de l'hôpital
        • Contact:
        • Principal Investigator:
          • Gilbert MASSARD, MD
        • Sub-Investigator:
          • Pierre-Emmanuel FALCOZ, MD
        • Sub-Investigator:
          • Nicola SANTELMO, MD
      • Strasbourg Cedex, France, 67091
        • Recruiting
        • Service de Physiologie et d'Explorations fonctionnelles - Nouvel Hôpital Civil - 1, Place de l'hôpital
        • Contact:
        • Principal Investigator:
          • Bernard GENY, MD
        • Sub-Investigator:
          • Anne CHARLOUX, MD
      • Strasbourg Cedex, France, 67091
        • Recruiting
        • Service de Pneumologie - Nouvel Hôpital Civil -1, Place de l'hôpital
        • Contact:
        • Principal Investigator:
          • Romain KESSLER, MD
        • Sub-Investigator:
          • Sandrine HIRSCHI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Lung transplant recipients cared for in Surgical Intensive Care Unit in Strasbourg University Hospital, France

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Julien Pottecher, MD, Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg Strasbourg, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

June 25, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

March 2, 2011

Last Update Submitted That Met QC Criteria

March 1, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4714

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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