Primary Graft Dysfunction Score in Lung Transplantation

Finding New Criteria for a Revised Primary Graft Dysfunction Score in Lung Transplantation - a Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplant; Complications
• Intervention / Treatment: Device: PiCCO Catheter

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Konrad Hoetzenecker, MD, PhD; Phone Number: 56990 0043140400; Email: konrad.hoetzenecker@meduniwien.ac.at
• Study Contact Backup: Name: Thomas Schweiger, MD, PhD; Phone Number: 56990 0043140400; Email: thomas.schweiger@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Konrad Hoetzenecker, MD,PhD; Phone Number: 56990 0043140400; Email: konrad.hoetzenecker@meduniwien.ac.at
    • Contact: Thomas Schweiger, MD,PhD; Phone Number: 56990 0043140400; Email: thomas.schweiger@meduniwien.ac.at
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Toronto General Hospital
      • Contact: Shaf Keshavjee, MD, MSc; Phone Number: 3863 001416340; Email: shaf.keshavjee@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving double lung transplantation

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary graft dysfunction	72 hours after transplantation

Collaborators and Investigators

• Sponsor: Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD
• Investigators: Principal Investigator: Konrad Hoetzenecker, MD, PhD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (ACTUAL): September 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Reperfusion Injury; Primary Graft Dysfunction
• Other Study ID Numbers: 1618/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared upon request

Drug and device information, study documents

• 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