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

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ClinicalTrials.gov Identifier: NCT01080625
Recruitment Status : Completed
First Posted : March 4, 2010
Results First Posted : April 12, 2012
Last Update Posted : May 3, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Hypotension After Reperfusion in Liver Transplantation Drug: phenylephrine Drug: epinephrine Drug: placebo control

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Preventive Medicine on the Postreperfusion Syndrome
Study Start Date : April 2010
Primary Completion Date : September 2011
Study Completion Date : October 2011

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Occurrence of Postreperfusion Syndrome (PRS) [ Time Frame: immediately after reperfusion ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- adults scheduled to undergo liver transplantation

Exclusion Criteria:

- pediatric liver transplantation

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080625

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

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
First Posted: March 4, 2010    Key Record Dates
Results First Posted: April 12, 2012
Last Update Posted: May 3, 2012
Last Verified: May 2012

Keywords provided by Chul-Woo Jung, Seoul National University Hospital:
postreperfusion syndrome
liver transplantation

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents
Cardiotonic Agents
Nasal Decongestants
Adrenergic alpha-1 Receptor Agonists
Protective Agents