Recruiting

Lung Transplantation

Sponsor:

Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD

Code:

NCT03276403

Conditions

Lung Transplant; Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PiCCO Catheter

Study Details

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.

Conditions

Lung Transplant; Complications

Study ID

NCT03276403

Start date

Nov 1, 2016

Status verified date

Sep, 2017

Completion date

Mar 1, 2018

Anticipated

Primary completion date

Dec 1, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Primary graft dysfunction [ Time Frame: 72 hours after transplantation ]

Central Contacts and Locations

Central contacts

Konrad Hoetzenecker, MD, PhD

0043140400konrad.hoetzenecker@meduniwien.ac.at

Thomas Schweiger, MD, PhD

0043140400thomas.schweiger@meduniwien.ac.at

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Shaf Keshavjee, MD, MSc

001416340shaf.keshavjee@uhn.ca

More Information

Sponsor

Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD

Last update posted

Sep 8, 2017

Last verified

Sep, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD on 2017-09-08.