Primary Graft Dysfunction Score in Lung Transplantation

Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD80 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Lung Transplant; Complications

Interventions

PiCCO CatheterDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Medical University of Vienna

Vienna, Austria

RECRUITING

Toronto General Hospital

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Primary graft dysfunction

Time frame: 72 hours after transplantation

Central Contacts

Konrad Hoetzenecker, MD, PhD

CONTACT

0043140400 konrad.hoetzenecker@meduniwien.ac.at

Thomas Schweiger, MD, PhD

CONTACT

0043140400 thomas.schweiger@meduniwien.ac.at

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.