Magnesium Administration in Liver Transplantation and Reperfusion Injury

NCT ID: NCT00994981

Last Updated: 2011-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-10-31

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.

Conditions

Living Donor Liver Transplantation; Reperfusion Injury

Keywords

magnesium and reperfusion injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

magnesium

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

magnesium sulfate; N/S

Eligibility Criteria

Inclusion Criteria

• adult patients scheduled for elective living donor liver transplantation

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Jeong Eun Kim

Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jong Ho Choi, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, School of Medicine, The Catholic University of Korea, Seoul Saint Mary's Hospital

Locations

The Catholic University of Korea, Seoul Saint Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

Mg-study-1

Identifier Type: -

Identifier Source: secondary_id

Mg-study

Identifier Type: -

Identifier Source: org_study_id