Alcohol Withdrawal Clinical Trial
— AToM1Official title:
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
Verified date | July 2019 |
Source | Glasgow Royal Infirmary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 127 |
Est. completion date | June 19, 2018 |
Est. primary completion date | April 2, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Glasgow Royal Infirmary | Glasgow |
Lead Sponsor | Collaborator |
---|---|
Glasgow Royal Infirmary |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Erythrocyte transketolase activity | this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin | 0 and 2 hours | |
Primary | Change in serum lactate | Biochemical marker of metabolic dysfunction (expressed as mmol/L) | 0 and 2 hours | |
Primary | Change in rate of resolution of alcohol withdrawal syndrome | time | days | |
Secondary | lactate dehydrogenase | biochemical (expressed in mmol/L) | 0 and 2 hours | |
Secondary | pre and post magnesium | biochemical (expressed in mmol/L) | 0 and 2 hours | |
Secondary | pre and post red cell thiamine | biochemical | 0 and 2 hours | |
Secondary | establish baseline micronutrient status of patients with alcohol withdrawal syndrome | biochemical | o and 2 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03916939 -
Osteopathic Treatment to Alcohol Withdrawal Syndrome
|
N/A | |
Completed |
NCT04858490 -
Remote Treatment of Alcohol Withdrawal
|
N/A | |
Not yet recruiting |
NCT04997330 -
Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction
|
N/A | |
Recruiting |
NCT04876443 -
Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease (ICoLD)
|
||
Completed |
NCT05131334 -
Auricular Vagal Stimulation in Alcohol Craving
|
N/A | |
Completed |
NCT02349477 -
Gabapentin for Alcohol Relapse Prevention
|
Phase 2 | |
Terminated |
NCT01937364 -
Preventing Alcohol Withdrawal With Oral Baclofen
|
Phase 2 | |
Completed |
NCT05393544 -
Digitally Assisted Recovery Coach
|
N/A | |
Completed |
NCT00523185 -
A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal
|
N/A | |
Completed |
NCT01573052 -
Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal
|
Phase 4 | |
Enrolling by invitation |
NCT06173973 -
Effects of Ketone Supplementation on Acute Alcohol Withdrawal
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03737864 -
NCARE, Transition to Recovery
|
N/A | |
Recruiting |
NCT03878225 -
Does a Ketogenic Dietary Supplement Reduce Alcohol Withdrawal Symptoms in Humans?
|
N/A | |
Terminated |
NCT03586089 -
Phenobarbital for Severe Acute Alcohol Withdrawal Syndrome
|
N/A | |
Recruiting |
NCT04156464 -
Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit
|
Phase 4 | |
Completed |
NCT02202148 -
Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
|
N/A | |
Completed |
NCT02251912 -
Oxytocin Treatment of Alcohol Dependence
|
Phase 2 | |
Completed |
NCT01212185 -
Oxytocin Treatment of Alcohol Withdrawal
|
Phase 1 | |
Recruiting |
NCT04793685 -
Prazosin for Alcohol Use Disorder With Withdrawal Symptoms
|
Phase 1/Phase 2 | |
Withdrawn |
NCT04159909 -
Using Transcutaneous Auricular Vagus Nerve Stimulation to Treat Acute Alcohol Withdrawal
|
N/A |