The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.
Full Title of Study: “Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2014
- Drug: Prednisone plus Metadoxine
- Drug: Pentoxifylline plus Metadoxine
Arms, Groups and Cohorts
- No Intervention: Prednisone
- Prednisone 40 mg daily by mouth during 30 days.
- No Intervention: Pentoxifylline
- Pentoxifylline 400 mg thrice in day by mouth during 30 days
- Experimental: Prednisone plus metadoxine
- Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
- Experimental: Pentoxifylline plus metadoxine
- Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
Clinical Trial Outcome Measures
- 30 day-survival
- Time Frame: 30 days
- Malondialdehyde serum levels
- Time Frame: 14 and 30 days
- 3 month-survival
- Time Frame: 3 months
- 6 month-survival
- Time Frame: 6 months
Participating in This Clinical Trial
- Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32. Exclusion Criteria:
- Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Hospital General de Mexico
- Provider of Information About this Clinical Study
- Principal Investigator: MARIA DE FATIMA HIGUERA DE LA TIJERA, MD, MSc. – Hospital General de Mexico
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