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Primary Graft Dysfunction Score in Lung Transplantation

Sponsor
Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD (Other)
Overall Status
Unknown status
CT.gov ID
NCT03276403
Collaborator
(none)
80
Enrollment
2
Locations
15.9
Anticipated Duration (Months)
40
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: PiCCO Catheter

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Finding New Criteria for a Revised Primary Graft Dysfunction Score in Lung Transplantation - a Pilot Study
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Mar 1, 2018

Outcome Measures

Primary Outcome Measures

  1. Primary graft dysfunction [72 hours after transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Double lung transplantation for primary pulmonary hypertension (PPH), Fibrosis, cystic fibrosis (CF), Emphysema

  • No restrictions regarding donor lungs (marginal donors, EVLP possible)

  • No restrictions regarding size reduction (anatomic wedge resections, three lobar, lobar transplantations)

Exclusion Criteria:

  • Single-lung transplantation

  • Heart-lung transplantation

  • Re-transplantation

  • Patients with bridge-to-transplantation with a mechanical assist device (extra-corporal membrane oxygenation (v/v, v/a), PA/LA Novalung, ILAactive, ILA)

  • Clinical situations leading to inaccurate PiCCO measurements e.g. intracardiac shunts, significant tricuspid regurgitation, cooling

  • No access to the femoral artery possible

  • Severe postoperative hemorrhage, which leads to hematothorax and makes revision surgery necessary

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090
2 Toronto General Hospital Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Konrad Hoetzenecker, MD, PhD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD, Assoc.-Prof. Dr. Konraf Hoetzenecker, PhD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT03276403
Other Study ID Numbers:
  • 1618/2016
First Posted:
Sep 8, 2017
Last Update Posted:
Sep 8, 2017
Last Verified:
Sep 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Primary Graft Dysfunction

Study Results

No Results Posted as of Sep 8, 2017