NCT01151826

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 2, 2011

Status Verified

March 1, 2011

Enrollment Period

2.1 years

First QC Date

June 25, 2010

Last Update Submit

March 1, 2011

Conditions

Primary Graft Dysfunction

Keywords

Lung transplantationPrimary Graft DysfunctionExtravascular Lung WaterReceptor for Advanced Glycation Endproducts (RAGE)Intercellular Adhesion Molecule-1 (ICAM-1)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Lung transplant recipient
  • Age \> 18 years
  • Signed informed consent
  • Social security affiliation

You may not qualify if:

  • Age\<18
  • Pregnancy or lactation
  • Contraindication to femoral arterial catheterization
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Strasbourg, 67091, France

RECRUITING

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

Strasbourg, 67091, France

RECRUITING

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

Strasbourg, 67091, France

RECRUITING

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

Strasbourg, 67091, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27495752DERIVED

MeSH Terms

Conditions

Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Reperfusion InjuryVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Julien Pottecher, MD

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

    STUDY DIRECTOR

Central Study Contacts

Julien Pottecher, MD

CONTACT

33 3 69 55 04 44julien.pottecher@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2010

First Posted

June 28, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 2, 2011

Record last verified: 2011-03

Locations

FR(4)