Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation
Effect of Preventive Medicine on the Postreperfusion Syndrome
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2010
CompletedFirst Posted
Study publicly available on registry
March 4, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
April 12, 2012
CompletedMay 3, 2012
May 1, 2012
1.4 years
March 2, 2010
February 13, 2012
May 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
immediately after reperfusion
Study Arms (3)
phenylephrine
EXPERIMENTAL100 mcg of phenylephrine is administered at the time of reperfusion
epinephrine
EXPERIMENTAL10 mcg of epinephrine is administered iv at the time of reperfusion
control
PLACEBO COMPARATOR10 ml of normal saline is administered at the time of reperfusion
Interventions
10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion
Eligibility Criteria
You may qualify if:
- \- adults scheduled to undergo liver transplantation
You may not qualify if:
- \- pediatric liver transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 22821620DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chul-Woo Jung/ Assistant professor
- Organization
- SNUH
Study Officials
- PRINCIPAL INVESTIGATOR
Chul-Woo Jung, MD
Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
March 2, 2010
First Posted
March 4, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
May 3, 2012
Results First Posted
April 12, 2012
Record last verified: 2012-05