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Status unknownNCT03276403Updated Sep 8, 2017

Primary Graft Dysfunction Score in Lung Transplantation

An observational study in Lung Transplant; Complications, sponsored by Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-09-08.

Sponsored by Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Transplant; Complications
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving double lung transplantation

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

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.

05

What researchers measure

Primary outcomes

  1. Primary graft dysfunction

    Time frame: 72 hours after transplantation

06

Study locations

2 of 2 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — IPD will be shared upon request

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03276403
Lead sponsor
Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD
Responsible party
Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD (Assoc.-Prof. Dr. Konraf Hoetzenecker, PhD, Medical University of Vienna) — Sponsor-investigator
First posted
Sep 8, 2017
Start date
Nov 1, 2016
Primary completion
Dec 1, 2017 (estimated)
Completion
Mar 1, 2018 (estimated)
Last update
Sep 8, 2017

Study contacts

Konrad Hoetzenecker, MD, PhD
Contact
konrad.hoetzenecker@meduniwien.ac.at
0043140400 ext. 56990
Thomas Schweiger, MD, PhD
Contact
thomas.schweiger@meduniwien.ac.at
0043140400 ext. 56990
Konrad Hoetzenecker, MD, PhD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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