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Anesthetic Methods and Liver Transplantation

Primary Purpose

Acute Lung Injury

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
propofol during liver transplantation.
Desflurane during liver transplantation.
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Lung Injury focused on measuring Liver transplantation, reactive oxygen species, antioxidant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • End stage liver disease scheduled for liver transplantation in National Taiwan University Hospital

Exclusion Criteria:

  • Pre-existing pulmonary disease
  • coma

Sites / Locations

  • Department of Anesthesiology, NTUH, Taipei, TaiwanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

propofol

Desflurane

Arm Description

The anesthesia was maintained with propofol during liver transplantation.

The anesthesia was maintained with desflurane during liver transplantation.

Outcomes

Primary Outcome Measures

Change of cardiac output perioperatively
Cardiac output(l/min) was measured by thermodilution method perioperatively.

Secondary Outcome Measures

lung injury score
PaO2/FiO2(Arterial oxygen tension/fraction of inspired oxygen)

Full Information

First Posted
August 27, 2013
Last Updated
July 22, 2015
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01936545
Brief Title
Anesthetic Methods and Liver Transplantation
Official Title
The Impact of Different Anesthetic Methods on Ischemia Reperfusion Injury Following Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Postoperative pulmonary complications are not uncommon after liver transplantation. They can not only prolong the stay in intensive care unit and in hospital but also increase the morbidity and mortality rate. The underlying mechanisms are multifactorial, however, oxidative stress following hepatic ischemia reperfusion and the ensuing pulmonary leukocyte infiltration play an important part in the pulmonary complications. Various drugs and methods such as ischemic preconditioning have been used to lessen the production of oxidative free radicals following hepatic ischemia reperfusion. The choice of different anesthetic agents could aslo change the degree of production of oxygen species and antioxidant capacity during the operation. Volatile and intravenous anesthetic agents can decrease oxidative injuries through different mechanisms, however, which is better in preventing the pulmonary leukocyte infiltration is still unknown. We attempt the compare the oxidative stress and cytokine level in liver transplant recipients under desflurane or propofol anesthesia to evaluate which kind of anesthetic agent is better in this kind of surgery.
Detailed Description
The occurrence of postoperative pulmonary complications after hepatic reperfusion, such as in patients undergoing liver transplantation, is a major concern in the intensive care unit. Not only neutrophil infiltration, but also oxidative injuries, have been demonstrated after intra-operative hepatic ischemia/reperfusion (I/R) management. Previous studies have shown that reactive oxygen species (ROS) paly a major role in the ensuing damage, although I/R-induced remote organ injury is a complex and multifactorial process. Methods to reduce ROS generation, such as ischemic preconditioning, attenuate both liver and lung damage after hepatic I/R. Considering the intra-operative ROS production occurs after hepatic reperfusion , the choice of anesthetics may alter the magnitude of ROS production and the antioxidant capacity. Volatile and non-volatile anesthetics can exert their antioxidant capacity through different mechanisms. Propofol (2,6-diisopropylphenol) has been reported to provide antioxidant capacity by scavenging free radicals. However, volatile anesthetics such as isoflurane, desflurane or sevoflurane can reduce the oxidative damage through anesthetic preconditioning. Several animal studies demonstrate that volatile anesthetics offer more protection against ischemia-reperfusion injury than intravenous anesthetics. On the contrary, intravenous anesthetics may be more protective against sepsis-induced hepatic injury than volatile anesthetics. However, there are few investigations concerning the effects of different anesthetics on remote pulmonary injuries in clinical settings. In this study, propofol and desflurane will be used for the maintenance of anesthesia during liver transplantation. The heart function, respiratory function, liver function, kidney function, the oxidative injuries and inflammatory mediators will be compared between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
Liver transplantation, reactive oxygen species, antioxidant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
propofol
Arm Type
Experimental
Arm Description
The anesthesia was maintained with propofol during liver transplantation.
Arm Title
Desflurane
Arm Type
Active Comparator
Arm Description
The anesthesia was maintained with desflurane during liver transplantation.
Intervention Type
Drug
Intervention Name(s)
propofol during liver transplantation.
Other Intervention Name(s)
propofol
Intervention Description
The anesthesia was maintained with propofol during liver transplantation.
Intervention Type
Drug
Intervention Name(s)
Desflurane during liver transplantation.
Other Intervention Name(s)
Desflurane
Intervention Description
The anesthesia was maintained with desflurane during liver transplantation.
Primary Outcome Measure Information:
Title
Change of cardiac output perioperatively
Description
Cardiac output(l/min) was measured by thermodilution method perioperatively.
Time Frame
one week
Secondary Outcome Measure Information:
Title
lung injury score
Description
PaO2/FiO2(Arterial oxygen tension/fraction of inspired oxygen)
Time Frame
one week
Other Pre-specified Outcome Measures:
Title
Reactive oxygen species
Description
Reactive oxygen species measured by chemiluminescence method
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: End stage liver disease scheduled for liver transplantation in National Taiwan University Hospital Exclusion Criteria: Pre-existing pulmonary disease coma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuang Cheng Chan, M.D.
Phone
886-2-23123456
Ext
62158
Email
jkjchan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuang Cheng Chan, M.D.
Organizational Affiliation
Department of Anesthesiology, NTUH, Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, NTUH, Taipei, Taiwan
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuang Cheng Chan, M.D.
First Name & Middle Initial & Last Name & Degree
Kuang Cheng Chan, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
12827567
Citation
Aduen JF, Stapelfeldt WH, Johnson MM, Jolles HI, Grinton SF, Divertie GD, Burger CD. Clinical relevance of time of onset, duration, and type of pulmonary edema after liver transplantation. Liver Transpl. 2003 Jul;9(7):764-71. doi: 10.1053/jlts.2003.50103.
Results Reference
background
PubMed Identifier
31111072
Citation
Wu CY, Cheng YJ, Hung MH, Lin IJ, Sun WZ, Chan KC. Association between Early Acute Respiratory Distress Syndrome after Living-Donor Liver Transplantation and Perioperative Serum Biomarkers: The Role of Club Cell Protein 16. Biomed Res Int. 2019 Apr 11;2019:8958069. doi: 10.1155/2019/8958069. eCollection 2019.
Results Reference
derived

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Anesthetic Methods and Liver Transplantation

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