Magnesium Administration in Liver Transplantation and Reperfusion Injury

NCT00994981 | Completed Phase 4 DMC

• 2 other identifiers: Mg-studyMg-study-1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Living Donor Liver Transplantation; Reperfusion Injury

Keywords

magnesium and reperfusion injury

Outcome Measures

Primary Outcomes (1)

• blood lactate level

  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

  preoperatively and on POD 1 and POD 5

Study Arms (2)

magnesium

EXPERIMENTAL

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

normal saline

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: magnesium sulfate

magnesium

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.

Also known as: N/S

normal saline

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients scheduled for elective living donor liver transplantation

You may not qualify if:

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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

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

Seoul, 137-040, South Korea

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Magnesium; Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jong Ho Choi, professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

KR (1)