NCT02412800

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

9 months

First QC Date

April 6, 2015

Last Update Submit

October 28, 2015

Conditions

Keywords

Extravascular lung waterPulmonary vascualr permeability indexLiver transplantation

Outcome Measures

Primary Outcomes (1)

  • Postoperative acute lung injury

    72 hours

Study Arms (1)

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.

Eligibility Criteria

Age6 Months - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Kuang Cheng Chan, M.D.

    Natioanal Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang Cheng Chan, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 9, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations