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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
History of Changes
Results First Received: February 13, 2012  
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
Condition: Hypotension After Reperfusion in Liver Transplantation
Interventions: Drug: phenylephrine
Drug: epinephrine
Drug: placebo control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of the 128 eligible candidates, 96 patients were enrolled in this study from Mar 2010 to Oct 2010 at SNUH.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Excluded(n=32) Children n=13 Coronary artery disease n=2 Valvular heart disease n=2 Atrial fibrillation n=1 Enrolled in other trial n=2 refusal to participate n=12

Randomized (n=96) intraop portal vein rupture n=1 data recording error n=1 procedure failure n=1

Analyzed n=93 (n=31 er each group)

Reporting Groups
  Description
Phenylephrine 100 mcg of phenylephrine is administered at the time of reperfusion
Epinephrine 10 mcg of epinephrine is administered iv at the time of reperfusion
Control 10 ml of normal saline is administered at the time of reperfusion

Participant Flow:   Overall Study
    Phenylephrine     Epinephrine     Control  
STARTED     31     33     32  
COMPLETED     31     31     31  
NOT COMPLETED     0     2     1  
Physician Decision                 0                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Phenylephrine 100 mcg of phenylephrine is administered at the time of reperfusion
Epinephrine 10 mcg of epinephrine is administered iv at the time of reperfusion
Control 10 ml of normal saline is administered at the time of reperfusion
Total Total of all reporting groups

Baseline Measures
    Phenylephrine     Epinephrine     Control     Total  
Number of Participants  
[units: participants]
 		  31     33     32     96  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     27     31     29     87  
>=65 years     4     2     3     9  
Age  
[units: years]
Mean ± Standard Deviation 		  52  ± 9     55  ± 10     52  ± 11     53  ± 10  
Gender  
[units: participants]
 		       
Female     10     9     7     26  
Male     21     24     25     70  
Region of Enrollment  
[units: participants]
 		       
Korea, Republic of     31     33     32     96  



  Outcome Measures

1.  Primary:   Occurrence of Postreperfusion Syndrome (PRS)   [ Time Frame: immediately after reperfusion ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Phenylephrine 100 mcg of phenylephrine is administered at the time of reperfusion
Epinephrine 10 mcg of epinephrine is administered iv at the time of reperfusion
Control 10 ml of normal saline is administered at the time of reperfusion

Other Adverse Events
    Phenylephrine     Epinephrine     Control  
Total, other (not including serious) adverse events        
# participants affected / at risk     0/31     0/33     0/32  



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Chul-Woo Jung/ Assistant professor
Organization: SNUH
phone: 82-2-2072-0640
e-mail: spss@snuh.org


No publications provided by Seoul National University Hospital

Publications automatically indexed to this study:


Responsible Party: Chul-Woo Jung, 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