Magnesium Administration in Liver Transplantation and Reperfusion Injury

Phase 4

Completed

• Conditions: Living Donor Liver Transplantation; Reperfusion Injury
• Interventions: Drug: normal saline; Drug: magnesium

• Registration Number: NCT00994981
• Lead Sponsor: The Catholic University of Korea

Brief Summary

The purpose of this study is to evaluate the effect of intravenous magnesium infusion before reperfusion with employing some clinical parameters including blood lactate levels, because the intraoperative changes in the blood lactate levels after hepatic allograft reperfusion served as an accurate predictor of the initial graft function in living donor liver transplantation.

Detailed Description

Clinically significant hemodynamic deterioration occurs immediately after reperfusion of the grafted liver by unclamping of the portal vein. Profound hypotension, bradycardia, systemic vasodilation, and a decrease in cardiac output have been reported, and this is described as postreperfusion syndrome (PRS). This hemodynamic instability usually requires adequate and aggressive cardiovascular pharmacologic management and fluid support, and recovers slowly over a period of 30 to 60 minutes.Because the severity of PRS correlates with patient and allograft outcome, prevention of its occurrence or attenuation of the hemodynamic changes may improve outcome. However, not much is known about how to protect against this reperfusion injury.

Reperfusion injury also occurs in myocardial infarction, ischemic spinal cord injury and stroke. Recent experiments have shown protective effects of magnesium to reduce the reperfusion injury of these conditions. Magnesium administration may provide cellular protection during ischemia and reperfusion with stabilizing the cellular transmembrane potential, suppressing excessive cellular calcium influx and energy demand.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-27
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• adult patients scheduled for elective living donor liver transplantation

Exclusion Criteria

• pediatric patients
• re-transplantation
• renal dysfunction
• cardiovascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	normal saline	Using a table of random numbers, the patients were randomized to receive magnesium solution or normal saline. Allocation concealment was ensured using sequentially numbered, sealed opaque envelopes. Immediately after patient's arrival in the operating room, an anesthesiologist who was not involved in this study opened the envelopes and prepared the study solution outside the operating room.
magnesium	magnesium	Using a table of random numbers, the patients were randomized to receive magnesium solution or normal saline. Allocation concealment was ensured using sequentially numbered, sealed opaque envelopes. Immediately after patient's arrival in the operating room, an anesthesiologist who was not involved in this study opened the envelopes and prepared the study solution outside the operating room.

Primary Outcome Measures

Name	Time	Method
blood lactate level	at 10 minutes after the beginning of the anhepatic phase and at 10, 30, 60 and 120 minutes after reperfusion

Secondary Outcome Measures

Name	Time	Method
aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and creatinine level	preoperatively and on POD 1 and POD 5

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul Saint Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of