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Magnesium Administration in Liver Transplantation and Reperfusion Injury

Primary Purpose

Living Donor Liver Transplantation, Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
magnesium
normal saline
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Living Donor Liver Transplantation focused on measuring magnesium and reperfusion injury

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients scheduled for elective living donor liver transplantation

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

magnesium

normal saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

blood lactate level

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2009
Last Updated
November 27, 2011
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00994981
Brief Title
Magnesium Administration in Liver Transplantation and Reperfusion Injury
Official Title
Does Pretreated Magnesium Protect Against Reperfusion Injury in Liver Transplanted Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Living Donor Liver Transplantation, Reperfusion Injury
Keywords
magnesium and reperfusion injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
magnesium
Arm Type
Experimental
Arm Description
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.
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
magnesium
Other Intervention Name(s)
magnesium sulfate
Intervention Description
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
Intervention Name(s)
normal saline
Other Intervention Name(s)
N/S
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and creatinine level
Time Frame
preoperatively and on POD 1 and POD 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients scheduled for elective living donor liver transplantation Exclusion Criteria: pediatric patients re-transplantation renal dysfunction cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Choi, professor
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, School of Medicine, The Catholic University of Korea, Seoul Saint Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea, Seoul Saint Mary's Hospital
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of

12. IPD Sharing Statement

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Magnesium Administration in Liver Transplantation and Reperfusion Injury

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