Status:
COMPLETED
Alcohol: Thiamine and or Magnesium 1
Lead Sponsor:
Glasgow Royal Infirmary
Conditions:
Alcohol Withdrawal
Lactic Acidosis
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
PHASE3
Brief Summary
Patients who suffer Alcohol Use Disorder (AUD) have a 30-80% incidence of thiamine deficiency causing Wernicke's Encephalopathy (WE). Intravenous (IV) thiamine replacement is standard practice in the...
Detailed Description
This is a 3- arm randomised, open label, controlled study in a cohort of alcoholic patients admitted through A\&E. Patients will be randomised to concurrent infusion of one of the following: * Arm 1:...
Eligibility Criteria
Inclusion
- Written informed consent
- Male or non-pregnant or breastfeeding females ≥18 years of age For women of child-bearing potential a negative pregnancy test will be required prior to treatment.
- (Women of non-childbearing potential are defined as those defined as women who are post-menopausal or permanently sterilised (e.g. hysterectomy, tubal occlusion, bilateral salpingectomy).
- • Chronic alcohol dependence as confirmed by
- FAST questionnaire
- GMAWS scale
Exclusion
- Unable to give consent
- Less than 18 years of age
- Chronic renal or hepatic failure/hepatic encephalopathy (investigator assessment as documented in past medical history i.e. Clinical Portal.)
- Known hypersensitivity or previous allergy to any of the active substances in either trial medication, or to excipients
- Severe concurrent medical condition that would prevent participation in study procedures (e.g. myasthenia gravis, clinically significant cardiac disease, or cardiac failure with severe pulmonary oedema)
Key Trial Info
Start Date :
December 16 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2018
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT03466528
Start Date
December 16 2016
End Date
June 19 2018
Last Update
July 31 2019
Active Locations (1)
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1
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF