Magnesium Administration in Liver Transplantation and Reperfusion Injury - Full Text View

Purpose

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.

Condition	Intervention	Phase
Living Donor Liver Transplantation Reperfusion Injury	Drug: magnesium Drug: normal saline	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Does Pretreated Magnesium Protect Against Reperfusion Injury in Liver Transplanted Patients?

Resource links provided by NLM:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Magnesium Magnesium sulfate Sulfate ion

U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and creatinine level [ Time Frame: preoperatively and on POD 1 and POD 5 ] [ Designated as safety issue: Yes ]

Enrollment:	61
Study Start Date:	September 2007
Study Completion Date:	October 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	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. Other Name: magnesium sulfate
Placebo Comparator: 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.	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. Other Name: N/S

Arms

Assigned Interventions

Experimental: 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.

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.

Other Name: magnesium sulfate

Placebo Comparator: 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.

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.

Other Name: N/S

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

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients scheduled for elective living donor liver transplantation

Exclusion Criteria:

pediatric patients
re-transplantation
renal dysfunction
cardiovascular disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994981

Locations

Korea, Republic of
The Catholic University of Korea, Seoul Saint Mary's Hospital
Seoul, Korea, Republic of, 137-040

Sponsors and Collaborators

The Catholic University of Korea

Investigators

Principal Investigator:

Jong Ho Choi, professor

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

More Information

No publications provided

Responsible Party:	Jeong Eun Kim, Department of Anesthesiology, The Catholic University of Korea
ClinicalTrials.gov Identifier:	NCT00994981 History of Changes
Other Study ID Numbers:	Mg-study, Mg-study-1
Study First Received:	October 13, 2009
Last Updated:	November 27, 2011
Health Authority:	Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:

magnesium and reperfusion injury

Additional relevant MeSH terms:

Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 16, 2013