Primary Graft Dysfunction Score in Lung Transplantation

Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD

Status: Unknown

Conditions: Lung Transplant; Complications

Treatments: Device: PiCCO Catheter

Study type: Observational

Funder types: Other

Identifiers

NCT03276403

1618/2016

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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