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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03276403

Enrollment

Registered

2017-09-08

Start date

2016-11-01

Completion date

2018-03-01

Last updated

2017-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant; Complications

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.

Interventions

DEVICEPiCCO 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Primary graft dysfunction	72 hours after transplantation

Countries

Austria, Canada

Contacts

Primary ContactKonrad Hoetzenecker, MD, PhD

konrad.hoetzenecker@meduniwien.ac.at0043140400

Backup ContactThomas Schweiger, MD, PhD

thomas.schweiger@meduniwien.ac.at0043140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026