- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01899248
The Effect of Inhalation Agent on the QTc Interval During Liver Transplantation: Sub Study (NCT01886664)
May 13, 2014 updated by: Seoul National University Hospital
The purpose of this study is to assess the effects of inhalation agent on corrected QT interval duration during liver transplantation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
52
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
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
subjects who were enrolled prospectively in study (ClinicalTrials.gov
Identifier NCT01886664)
Description
Inclusion Criteria:
- elective liver transplantation
Exclusion Criteria:
- age < 18, age > 65
- patient refusal
- re-transplantation
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 |
Intervention / Treatment |
---|---|
Sevoflurane
Performing liver transplantation under general anesthesia using sevoflurane
|
|
Desflurane
Performing liver transplantation under general anesthesia using desflurane
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
corrected QT interval (QTc interval)
Time Frame: up to postoperative day 1 after surgery
|
up to 10 minutes after tracheal intubation, up to 60 minutes after reperfusion, at 10 minutes after hepatectomy, at 10 minutes after biliary anastomosis, at skin closure, at the arrival on ICU, on postoperative day 1.
|
up to postoperative day 1 after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proportion of patients whose QTc interval is more than 450 ms for men and 470 ms for women
Time Frame: up to postoperative day 1 after surgery
|
up to postoperative day 1 after surgery
|
|
proportion of patients who have more than 500 ms of QTc interval
Time Frame: up to postoperative day 1 after surgery
|
up to postoperative day 1 after surgery
|
|
Tp-e interval
Time Frame: up to postoperative day 1 after surgery
|
up to 10 minutes after tracheal intubation, up to 60 minutes after reperfusion, at 10 minutes after hepatectomy, at 10 minutes after biliary anastomosis, at skin closure, at the arrival on ICU, on postoperative day 1.
|
up to postoperative day 1 after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
December 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
July 10, 2013
First Submitted That Met QC Criteria
July 10, 2013
First Posted (Estimate)
July 15, 2013
Study Record Updates
Last Update Posted (Estimate)
May 14, 2014
Last Update Submitted That Met QC Criteria
May 13, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YSJeon_liver transplantation
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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