A Prospective Randomised Controlled Trial of the Effect of Magnesium Sulphate Administration on Red Cell Transketolase Activity in Alcohol Dependent Patients at Risk of Wernicke Korsakoff Syndrome Treated With Thiamine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Change in Erythrocyte transketolase activity
研究概览
简要总结
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 treatment of alcoholic patients presenting to the Accident & Emergency (A&E) department, however routine co-supplementation with magnesium (administered IV as magnesium sulphate ), which is required as a co-factor for thiamine in some metabolic processes, e. g. on the activity of the enzyme transketolase in red blood cells, is not routine practice in the treatment of these patients. Without correction of concomitant magnesium deficiency there may be impaired utilisation of thiamine resulting in a failure to treat WE.
This study is designed to determine if administration of magnesium to AUD patients affects red cell transketolasae and serum lactate concentrations by itself, or only acts to increase the effect of thiamine on the activity of this enzyme.
详细描述
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: IV thiamine
- Arm 2: IV magnesium sulphate followed by delayed IV thiamine
- Arm 3: IV thiamine and IV magnesium sulphate Thiamine will be administered as IV Pabrinex, a compound preparation which also contains B vitamins and vitamin C. Administration of IV Pabrinex is standard care in this patient group and magnesium sulphate is routinely co-administered at Glasgow Royal Infirmary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Standard treatment - Pabrinex alone
Pabrinex alone
干预措施: Pabrinex (Drug)
Pabrinex + magnesium sulphate
standard treatment and magnesium sulphate
干预措施: Magnesium Sulfate (Drug)
Pabrinex + magnesium sulphate
standard treatment and magnesium sulphate
干预措施: Pabrinex (Drug)
Magnesium sulphate alone
This group receives the study intervention and delayed Pabrinex
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Change in Erythrocyte transketolase activity
时间窗: 0 and 2 hours
this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin
Change in serum lactate
时间窗: 0 and 2 hours
Biochemical marker of metabolic dysfunction (expressed as mmol/L)
Change in rate of resolution of alcohol withdrawal syndrome
时间窗: days
time
次要结局
- lactate dehydrogenase(0 and 2 hours)
- pre and post magnesium(0 and 2 hours)
- pre and post red cell thiamine(0 and 2 hours)
- establish baseline micronutrient status of patients with alcohol withdrawal syndrome(o and 2 hours)
研究者
Dr. Donogh Maguire
Emergency Medicine Consultant
Glasgow Royal Infirmary