NCT01936545

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.

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
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

4.6 years

First QC Date

August 27, 2013

Last Update Submit

July 22, 2015

Conditions

Acute Lung Injury

Keywords

Liver transplantation, reactive oxygen species, antioxidant

Outcome Measures

Primary Outcomes (1)

  • Change of cardiac output perioperatively

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

    one week

Secondary Outcomes (1)

  • lung injury score

    one week

Other Outcomes (1)

  • Reactive oxygen species

    one week

Study Arms (2)

propofol

EXPERIMENTAL

The anesthesia was maintained with propofol during liver transplantation.

Drug: propofol during liver transplantation.

Desflurane

ACTIVE COMPARATOR

The anesthesia was maintained with desflurane during liver transplantation.

Drug: Desflurane during liver transplantation.

Interventions

propofol during liver transplantation.DRUG

The anesthesia was maintained with propofol during liver transplantation.

Also known as: propofol
propofol
Desflurane during liver transplantation.DRUG

The anesthesia was maintained with desflurane during liver transplantation.

Also known as: Desflurane
Desflurane

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pre-existing pulmonary disease
  • coma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, NTUH, Taipei, Taiwan

Taipei, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 12827567BACKGROUND

  • 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.

    PMID: 31111072DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Interventions

PropofolDesflurane

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Kuang Cheng Chan, M.D.

    Department of Anesthesiology, NTUH, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang Cheng Chan, M.D.

CONTACT

886-2-23123456jkjchan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 6, 2013

Study Start

May 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

TW(1)