Magnesium Administration in Liver Transplantation and Reperfusion Injury

Reperfusion Injury Clinical Trial

Official title:

Does Pretreated Magnesium Protect Against Reperfusion Injury in Liver Transplanted Patients?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994981
• Other study ID #: Mg-study
• Secondary ID: Mg-study-1
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2009
• Last updated: November 27, 2011
• Start date: September 2007
• Est. completion date: October 2008

Study information

• Verified date: November 2011
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult patients scheduled for elective living donor liver transplantation

Exclusion Criteria:

• pediatric patients

• re-transplantation

• renal dysfunction

• cardiovascular disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Living Donor Liver Transplantation
• Reperfusion Injury

Intervention

Drug:
• magnesium
Thirty minutes after the beginning of the anhepatic phase, the patients were received a magnesium solution (MgSO4 25 mg•kg-1 mixed in 100 ml of normal saline) over 20 minutes. A resident anesthesiologist, who was blinded to the group assignment, performed intravenous administration of the study solution and assessed study outcomes.
• normal saline
Thirty minutes after the beginning of the anhepatic phase, the patients were received 100 ml of normal saline over 20 minutes. A resident anesthesiologist, who was blinded to the group assignment, performed intravenous administration of the study solution and assessed study outcomes.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Seoul Saint Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood lactate level		at 10 minutes after the beginning of the anhepatic phase and at 10, 30, 60 and 120 minutes after reperfusion	Yes
Secondary	aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and creatinine level		preoperatively and on POD 1 and POD 5	Yes