Primary Graft Dysfunction Score in Lung Transplantation

Lung Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03276403
• Other study ID #: 1618/2016
• Status: Recruiting
• Phase: N/A
• First received: September 6, 2017
• Last updated: September 6, 2017
• Start date: November 1, 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: September 2017
• Source: Medical University of Vienna
• Contact: Konrad Hoetzenecker, MD, PhD
• Phone: 0043140400
• Email: konrad.hoetzenecker[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant; Complications
• Primary Graft Dysfunction

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD

Countries where clinical trial is conducted

Austria,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary graft dysfunction		72 hours after transplantation