Effect of Nafamostat on Postreperfusion Syndrome (PRS)
This study has been completed.
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01001403
First received: October 23, 2009
Last updated: May 4, 2010
Last verified: May 2010
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Purpose
This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Transplantation Postreperfusion Syndrome |
Drug: Nafamostat Drug: Normal saline |
Phase 4 |
| 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 Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS) [ Time Frame: during 5 min after reperfusion of liver graft ] [ Designated as safety issue: No ]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.
| Enrollment: | 62 |
| Study Start Date: | March 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: nafamostat
The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.
|
Drug: Nafamostat
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Chul Woo Jung, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01001403 History of Changes |
| Other Study ID Numbers: | CWJung_futhan-liver TPL |
| Study First Received: | October 23, 2009 |
| Results First Received: | March 21, 2010 |
| Last Updated: | May 4, 2010 |
| Health Authority: | Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Nafamostat Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |
Anticoagulants Hematologic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Trypsin Inhibitors Serine Proteinase Inhibitors Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013