Effect of Clinical and Biochemical Variables Over Morbidity and Mortality in Alcohol Withdrawal S… (NCT06589973) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Clinical and Biochemical Variables Over Morbidity and Mortality in Alcohol Withdrawal Syndrome Patients
Mexico195 participantsStarted 2024-09-09
Plain-language summary
The goal of this observational study is to describe the impact measured through the Odds Ratio (OR) of different variables of clinical and biochemical alterations on the duration of the syndrome alcohol withdrawal patients measured in days of symptoms and stay; it could include any patients with a diagnosis of admission of alcohol withdrawal syndrome (AWS) who have been treated in the department of Internal Medicine for 5 years.
The main question it aims to answer is: What is the relationship between the different clinical, biochemical, and hematic factors on the duration of symptoms, morbidity, and mortality in individuals with alcohol syndrome withdrawal?
• If the patient has a greater number of risk factors, such as advanced age, a long and chronic history of alcohol consumption, the type of distillate consumed, as well as the deterioration of liver function and presence of leukocytosis and neutrophilia, then it is postulated that the duration of alcohol withdrawal syndrome will be longer.
Clinical records will be used to describe the proportion of complications associated with alcohol withdrawal syndrome including pneumonia bronchial aspiration, seizures, need for mechanical ventilation, digestive tract hemorrhage, toxic-alcoholic hepatitis, and pancreatitis.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical records of patients, both genders, over 18 years of age with Alcohol Withdrawal Syndrome according to the criteria for alcohol withdrawal.
* Clinical records of candidates for admission for neurological monitoring and with criteria for use of sedative drugs according to the CIWA-Ar scale
* Clinical records of patients containing the CIWA-Ar scale score at diagnosis
Exclusion Criteria:
* Clinical records of patients who already have a history of seizures or epilepsy
* Clinical records of diabetic patients with diabetic ketoacidosis
* Clinical records of patients who have not received any type of sedative treatment
* Clinical records of patients with chronic liver failure or liver cirrhosis
* Clinical records of patients with chronic liver disease with signs of hepatic encephalopathy
* Clinical records of patients with related toxic-alcoholic hepatitis
* Clinical records of patients with a life expectancy of less than 24 hours due to associated complications such as head trauma or other associated complications
* Clinical records of patients who require intubation and mechanical ventilation upon admission
* Clinical records of patients who have a vascular event that modifies the neurological evaluation
* Clinical records of patients who before admission show psychomotor alteration or neurological deterioration that modifies the neurological evaluation such as the presence of Wernicke's encephalopathy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.