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Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation

Primary Purpose

Hypotension After Reperfusion in Liver Transplantation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
phenylephrine
epinephrine
placebo control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension After Reperfusion in Liver Transplantation focused on measuring postreperfusion syndrome, phenylephrine, epinephrine, liver transplantation

Eligibility Criteria

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

Inclusion Criteria:

- adults scheduled to undergo liver transplantation

Exclusion Criteria:

- pediatric liver transplantation

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

phenylephrine

epinephrine

control

Arm Description

100 mcg of phenylephrine is administered at the time of reperfusion

10 mcg of epinephrine is administered iv at the time of reperfusion

10 ml of normal saline is administered at the time of reperfusion

Outcomes

Primary Outcome Measures

Occurrence of Postreperfusion Syndrome (PRS)
the number of patients who showed PRS (hypotension defined as < 30% of baseline mean arterial pressure [MAP] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group

Secondary Outcome Measures

Full Information

First Posted
March 2, 2010
Last Updated
May 1, 2012
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01080625
Brief Title
Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation
Official Title
Effect of Preventive Medicine on the Postreperfusion Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver transplantation which is characterized by an acute drop in blood pressure immediately after the prefusion is restored to the transplanted liver. We hypothesized that PRS would be prevented when phenylephrine or epinephrine is administered immediately prior to reperfusion in liver transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension After Reperfusion in Liver Transplantation
Keywords
postreperfusion syndrome, phenylephrine, epinephrine, liver transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
phenylephrine
Arm Type
Experimental
Arm Description
100 mcg of phenylephrine is administered at the time of reperfusion
Arm Title
epinephrine
Arm Type
Experimental
Arm Description
10 mcg of epinephrine is administered iv at the time of reperfusion
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
10 ml of normal saline is administered at the time of reperfusion
Intervention Type
Drug
Intervention Name(s)
phenylephrine
Intervention Description
100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion
Intervention Type
Drug
Intervention Name(s)
epinephrine
Intervention Description
10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion
Intervention Type
Drug
Intervention Name(s)
placebo control
Intervention Description
10ml of normal saline is administered at the time of reperfusion
Primary Outcome Measure Information:
Title
Occurrence of Postreperfusion Syndrome (PRS)
Description
the number of patients who showed PRS (hypotension defined as < 30% of baseline mean arterial pressure [MAP] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group
Time Frame
immediately after reperfusion

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: - adults scheduled to undergo liver transplantation Exclusion Criteria: - pediatric liver transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul-Woo Jung, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22821620
Citation
Ryu HG, Jung CW, Lee HC, Cho YJ. Epinephrine and phenylephrine pretreatments for preventing postreperfusion syndrome during adult liver transplantation. Liver Transpl. 2012 Dec;18(12):1430-9. doi: 10.1002/lt.23511.
Results Reference
derived

Learn more about this trial

Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation

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