NCT03276403

Primary Graft Dysfunction Score in Lung Transplantation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-12-01
• Completion: 2018-03-01
• First posted: 2017-09-08
• Last updated: 2017-09-08

Locations

2 sites across 2 countries: Austria, Canada

Regulatory

• FDA-regulated device study