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NCT Number: NCT06589973

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Cuautitlan "General José Vicente Villada"

Mexico City, 54800, Mexico

Location status: Recruiting

Location contact

Yossadara Hernández Ángeles, MD

CONTACT

[email protected]

55 5872 1754

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Death

    Time frame: 6 months

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

  2. Morbidity

    Time frame: 6 months

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

Secondary outcomes

  1. Hospital stay

    Time frame: 6 months

    Time recorded in the clinical record of the duration of symptoms from the first clinical manifestation until the time of discharge.

  2. Duration of symptoms

    Time frame: 6 months

    Time recorded in the clinical record of the duration of symptoms from the first clinical manifestation to the description of improvement in the medical notes

Study contacts

Contact information is provided by the study sponsor or research team.

Christian O Ramos Peñafiel, PhD

CONTACT

[email protected]

5527892000 ext. 1420

Yossadara Hernández Ángeles, MD

CONTACT

[email protected]

5523351588

Sponsors and collaborators

Lead sponsor

Hospital General de Mexico

Other Gov

Registry information

Official study title

IImpact of Clinical and Biochemical Variables on Mortality and Morbidity of Patients With Alcohol Withdrawal Syndrome Under Treatment According to the CIWA-AR Scale"

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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