Magnesium Administration in Liver Transplantation and Reperfusion Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeong Eun Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00994981
First received: October 13, 2009
Last updated: November 27, 2011
Last verified: November 2011
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014