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Completed

NCT Number: NCT00994981

Magnesium Administration in Liver Transplantation and Reperfusion Injury

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.

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Key information

Conditions

Living Donor Liver Transplantation Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Seoul, 137-040, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients scheduled for elective living donor liver transplantation

Exclusion criteria

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

Treatment and study plan

Magnesium

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.

Other names: magnesium sulfate

normal saline

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.

Other names: N/S

Primary outcomes

  1. blood lactate level

    Time frame: at 10 minutes after the beginning of the anhepatic phase and at 10, 30, 60 and 120 minutes after reperfusion

Secondary outcomes

  1. aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and creatinine level

    Time frame: preoperatively and on POD 1 and POD 5

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 14, 2009
Registry last updated
Nov 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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