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

NCT ID: NCT01151826

Last Updated: 2011-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Primary Graft Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Strasbourg, France

Principal Investigators

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Julien Pottecher, MD

Role: STUDY_DIRECTOR

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

Locations

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Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Service de Chirurgie thoracique - Nouvel Hôpital Civil - 1, Place de l'hôpital

Strasbourg, , France

Site Status RECRUITING

Service de Physiologie et d'Explorations fonctionnelles - Nouvel Hôpital Civil - 1, Place de l'hôpital

Strasbourg, , France

Site Status RECRUITING

Service de Pneumologie - Nouvel Hôpital Civil -1, Place de l'hôpital

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julien Pottecher, MD

Role: CONTACT

[email protected]
33 3 69 55 04 44

Facility Contacts

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Julien Pottecher, MD

Role: primary

[email protected]
33 3 69 55 04 44

Gilbert MASSARD, MD

Role: primary

[email protected]
33 3 69 55 07 98

Bernard GENY, MD

Role: primary

[email protected]
33 3 69 55 08 79

Romain KESSLER, MD

Role: primary

[email protected]
33 3 69 55 06 45

References

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Pottecher J, Roche AC, Degot T, Helms O, Hentz JG, Schmitt JP, Falcoz PE, Santelmo N, Levy F, Collange O, Uring-Lambert B, Bahram S, Schaeffer M, Meyer N, Geny B, Lassalle P, Diemunsch P, Massard G, Kessler R, Steib A; Groupe de Transplantation Pulmonaire des Hopitaux Universitaires de Strasbourg. Increased Extravascular Lung Water and Plasma Biomarkers of Acute Lung Injury Precede Oxygenation Impairment in Primary Graft Dysfunction After Lung Transplantation. Transplantation. 2017 Jan;101(1):112-121. doi: 10.1097/TP.0000000000001434.

Reference Type DERIVED
PMID: 27495752 (View on PubMed)

Other Identifiers

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4714

Identifier Type: -

Identifier Source: org_study_id

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