Primary Graft Dysfunction Score in Lung Transplantation

• Conditions: Lung Transplant; Complications

• Registration Number: NCT03276403
• Lead Sponsor: Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Status Verified: 2017-09
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-06
• Last Update Submitted: 2017-09-06
• Study First Posted: 2017-09-08
• Last Update Posted: 2017-09-08
• Primary Completion: 2017-12-01
• Study Completion: 2018-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary graft dysfunction	72 hours after transplantation

Trial Locations

Locations (2)

Medical University of Vienna; 🇦🇹 Vienna, Austria

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada