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Primary Graft Dysfunction Score in Lung Transplantation

NCT03276403 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2017-09-08

No results posted yet for this study

Summary

The validity of several functional parameters, which could be included in a new PGD scoring system, will be tested in a prospective pilot study of 80 consecutive bilateral lung transplant recipients in high volume lung transplant centers. Functional parameters will be collected at different time points within the first 72hrs after lung transplantation and their accuracy in predicting clinical outcome as well as their correlation with lung water content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a novel PGD score), which can then be tested in future prospective trials.

Conditions

  • Lung Transplant; Complications

Interventions

DEVICE

PiCCO Catheter

The PiCCO Catheter is an investigational device intended to measure lung water content in individuals requiring advanced haemodynamic monitoring. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.

Sponsors & Collaborators

  • Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD

    lead OTHER

Principal Investigators

  • Konrad Hoetzenecker, MD, PhD · Medical University of Vienna

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2017-12-01
Completion
2018-03-01
FDA Device
Yes

Countries

  • Austria
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03276403 on ClinicalTrials.gov