Clinical trial NCT00994981: Magnesium Administration in Liver Transplantation and Reperfusion Injury
Official title: Does Pretreated Magnesium Protect Against Reperfusion Injury in Liver Transplanted Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Living Donor Liver Transplantation
Reperfusion Injury
Keywords: magnesium and reperfusion injury
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for elective living donor liver transplantation

Exclusion Criteria:

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

Primary outcomes:
measure: blood lactate level
timeFrame: at 10 minutes after the beginning of the anhepatic phase and at 10, 30, 60 and 120 minutes after reperfusion
Secondary outcomes:
measure: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and creatinine level
timeFrame: preoperatively and on POD 1 and POD 5
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul Saint Mary's Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, School of Medicine, The Catholic University of Korea, Seoul Saint Mary's Hospital
name: Jong Ho Choi, professor
role: PRINCIPAL_INVESTIGATOR
References: