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

Hypotension After Reperfusion in Liver Transplantation Clinical Trial

Official title:

Effect of Preventive Medicine on the Postreperfusion Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080625
• Other study ID #: CWJung_phen_epi_liver TPL
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: May 1, 2012
• Start date: April 2010
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adults scheduled to undergo liver transplantation

Exclusion Criteria:

• pediatric liver transplantation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension
• Hypotension After Reperfusion in Liver Transplantation

Intervention

Drug:
• phenylephrine
100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion
• epinephrine
10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion
• placebo control
10ml of normal saline is administered at the time of reperfusion

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No