Risk Factors of Postoperative Acute Lung Injury Following Liver Transplantation

Acute Lung Injury Clinical Trial

Official title:

Risk Factors of Postoperative Acute Lung Injury Following Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02412800
• Other study ID #: 201412036RINC
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2015
• Last updated: October 28, 2015
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: October 2015
• Source: National Taiwan University Hospital
• Contact: Kuang Cheng Chan, M.D.
• Phone: +886-2-23123456
• Email: jkjchan[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative acute lung injury		72 hours	No