Primary Graft Dysfunction Score in Lung Transplantation

NCT03276403 | Unknown FDA Device

• 1 other identifier: 1618/2016
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 2

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.

Conditions

Lung Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Primary graft dysfunction

  72 hours after transplantation

Interventions

PiCCO Catheter DEVICE

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 Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving double lung transplantation

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Study Officials

• Konrad Hoetzenecker, MD, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad Hoetzenecker, MD, PhD

CONTACT

0043140400; konrad.hoetzenecker@meduniwien.ac.at

Thomas Schweiger, MD, PhD

CONTACT

0043140400; thomas.schweiger@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc.-Prof. Dr. Konraf Hoetzenecker, PhD

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

CA (1); AU (1)