Effect of Clinical and Biochemical Variables Over Morbidity and Mortality in Alcohol Withdrawal Syndrome Patients

NCT06589973 | Recruiting DMC

• 1 other identifier: 606023-01-1624
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Withdrawal Syndrome

Outcome Measures

Primary Outcomes (2)

• Death

  Permanent cessation of all vital functions of an organism, including irreversible stopping of the heart and breathing

  6 months

• Morbidity

  Any type of complication present during the analysis period that complicates the resolution of the condition, including serious situations.

  6 months

Secondary Outcomes (2)

• Hospital stay

  6 months

• Duration of symptoms

  6 months

Interventions

Study Cohort OTHER

Clinical records (files) of patients with a diagnosis of admission of alcohol withdrawal syndrome (AAS) who have been treated in the Department of Internal Medicine for 5 years.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Clinical records (case files) of patients with an admission diagnosis of alcohol withdrawal syndrome (AWS) who have been treated in the Internal Medicine department for 5 years will be analyzed.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General de Mexico: lead

Study Sites (1)

Hospital General de Cuautitlan "General José Vicente Villada"

Mexico City, 54800, Mexico

RECRUITING

MeSH Terms

Interventions

Cohort Studies

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Christian O Ramos Peñafiel, PhD

CONTACT

5527892000; leukemiachop33@gmail.com

Yossadara Hernández Ángeles, MD

CONTACT

5523351588; yossadara.ha@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 9, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 28, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)