Effect of Nafamostat on Postreperfusion Syndrome (PRS)
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|ClinicalTrials.gov Identifier: NCT01001403|
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : May 3, 2010
Last Update Posted : May 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation Postreperfusion Syndrome||Drug: Nafamostat Drug: Normal saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||April 2010|
The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.
0.2 mg/kg as bolus 1 minute before reperfusion
Placebo Comparator: Control
The control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft.
Drug: Normal saline
10 ml of normal saline
- Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS) [ Time Frame: during 5 min after reperfusion of liver graft ]Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. "Moderate" PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a "severe" form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001403
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|