Effect of Nafamostat on Postreperfusion Syndrome (PRS)

Phase 4

Completed

• Conditions: Postreperfusion Syndrome; Liver Transplantation
• Interventions: Drug: Normal saline; Drug: Nafamostat

• Registration Number: NCT01001403
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Primary Completion: 2010-03
• Results First Submitted: 2010-03-21
• Study Completion: 2010-04
• Results First Submitted QC: 2010-04-08
• Status Verified: 2010-05
• Results First Posted: 2010-05-03
• Last Update Submitted: 2010-05-04
• Last Update Posted: 2010-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• >= 18 year old scheduled to undergo liver transplantation

Exclusion Criteria

• Previous history of pulmonary, cardiovascular, or renal disease
• Previous history of allergic reactions to nafamostat

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	The control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft.
nafamostat	Nafamostat	The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of