Risk Factors of Postoperative Acute Lung Injury Following Liver Transplantation

October 28, 2015 updated by: National Taiwan University Hospital
Postoperative acute lung injury (ALI) during the first 72 hours after liver transplantation is not uncommon. Injury may occur because liver transplantation is often associated with prolonged operative time, large volumes of fluid administration and transfusion, as well as inflammatory responses related to ischemia-reperfusion injury. For more precise perioperative fluid and hemodynamic management, modern monitoring systems, such as the pulse contour cardiac output (PiCCO) system, have been devised and reported in recent years. The PiCCO system uses the thermodilution technique to determine the cardiac index (CI) and thoracic fluid indices such as the intrathoracic blood volume index (ITBVI), extravascular lung water index (EVLWI), and pulmonary vascular permeability index (PVPI), all of which may reflect pulmonary fluid and injury status. However, perioperative changes in thoracic fluid indices in liver transplantation and their associations with postoperative ALI are not yet clear. In this study, the investigators aimed to determine patterns of change in perioperative thoracic fluid indices and compare these changes in recipients who did or did not develop postoperative ALI. Furthermore, the investigators will also try to determine the potential risk factors following liver transplantation.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Kuang Cheng Chan, M.D.
          • Phone Number: 65522 +886-2-23123456
          • Email: jkjchan@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Liver transplant recipients in NTUH, Taipei, Taiwan. From 2004-2014.

Description

Inclusion Criteria:

  • End stage liver disease receiving liver transplantation in NTUH.
  • Age: 6 months old to 75 years old

Exclusion Criteria:

  • history of pulmonary resection,
  • chronic respiratory insufficiency
  • cardiac dysfunction
  • failure of the surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute lung injury
Postoperative acute lung injury was diagnosed according to the latest 2012 Berlin definition of acute respiratory distress syndrome by the PaO2/FiO2< 300 and acute onset of bilateral infiltrates on the chest radiograph that were not fully explained by cardiac failure during postoperative day 1 to postoperative day 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative acute lung injury
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Kuang Cheng Chan, M.D., Natioanal Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201412036RINC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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