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| ID | Type | Description | Link |
|---|---|---|---|
| 201773 | Other Identifier | IRAS |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment - Pabrinex alone | Active Comparator | Pabrinex alone |
|
| Pabrinex + magnesium sulphate | Active Comparator | standard treatment and magnesium sulphate |
|
| Magnesium sulphate alone | Experimental | This group receives the study intervention and delayed Pabrinex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erythrocyte transketolase activity | this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin | 0 and 2 hours |
| Change in serum lactate | Biochemical marker of metabolic dysfunction (expressed as mmol/L) | 0 and 2 hours |
| Change in rate of resolution of alcohol withdrawal syndrome | time | days |
| Measure | Description | Time Frame |
|---|---|---|
| lactate dehydrogenase | biochemical (expressed in mmol/L) | 0 and 2 hours |
| pre and post magnesium | biochemical (expressed in mmol/L) | 0 and 2 hours |
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Inclusion Criteria:
(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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donogh Maguire, MB BCh | NHS GGC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glasgow Royal Infirmary | Glasgow | G4 0SF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35484175 | Derived | Maguire D, Burns A, Talwar D, Catchpole A, Stefanowicz F, Ross DP, Galloway P, Ireland A, Robson G, Adamson M, Orr L, Kerr JL, Roussis X, Colgan E, Forrest E, Young D, McMillan DC. Randomised trial of intravenous thiamine and/or magnesium sulphate administration on erythrocyte transketolase activity, lactate concentrations and alcohol withdrawal scores. Sci Rep. 2022 Apr 28;12(1):6941. doi: 10.1038/s41598-022-10970-x. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2016 | Feb 19, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2016 | Mar 7, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000140 | Acidosis, Lactic |
| D001602 | Beriberi |
| D008275 | Magnesium Deficiency |
| D014899 | Wernicke Encephalopathy |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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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:
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| Pabrinex | Drug | standard treatment |
|
|
| pre and post red cell thiamine | biochemical | 0 and 2 hours |
| establish baseline micronutrient status of patients with alcohol withdrawal syndrome | biochemical | o and 2 hours |
| D013832 |
| Thiamine Deficiency |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |