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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chul-Woo Jung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01080625
First received: March 2, 2010
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Hypotension After Reperfusion in Liver Transplantation
Drug: phenylephrine
Drug: epinephrine
Drug: placebo control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Preventive Medicine on the Postreperfusion Syndrome

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Occurrence of Postreperfusion Syndrome (PRS) [ Time Frame: immediately after reperfusion ] [ Designated as safety issue: No ]
    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


Enrollment: 96
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: phenylephrine
100 mcg of phenylephrine is administered at the time of reperfusion
Drug: phenylephrine
100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion
Experimental: epinephrine
10 mcg of epinephrine is administered iv at the time of reperfusion
Drug: epinephrine
10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion
Placebo Comparator: control
10 ml of normal saline is administered at the time of reperfusion
Drug: placebo control
10ml of normal saline is administered at the time of reperfusion

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- adults scheduled to undergo liver transplantation

Exclusion Criteria:

- pediatric liver transplantation

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01080625

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chul-Woo Jung, MD Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chul-Woo Jung, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01080625     History of Changes
Other Study ID Numbers: CWJung_phen_epi_liver TPL
Study First Received: March 2, 2010
Results First Received: February 13, 2012
Last Updated: May 1, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
postreperfusion syndrome
phenylephrine
epinephrine
liver transplantation

Additional relevant MeSH terms:
Hypotension
Syndrome
Cardiovascular Diseases
Disease
Pathologic Processes
Vascular Diseases
Epinephrine
Epinephryl borate
Oxymetazoline
Phenylephrine
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 21, 2014