ClinicalTrials.gg
RecruitingNCT06589973Updated Sep 19, 2024

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

An observational study in Alcohol Withdrawal Syndrome, sponsored by Hospital General de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Hospital General de Mexico · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
195
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Alcohol Withdrawal Syndrome
03

In context

Lead sponsor

Hospital General de Mexico is the lead sponsor of 28 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
195 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • OtherStudy Cohort

    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.

06

What researchers measure

Primary outcomes

  1. Death

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

    Time frame: 6 months

  2. Morbidity

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

    Time frame: 6 months

Secondary outcomes

  1. Hospital stay

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

    Time frame: 6 months

  2. Duration of symptoms

    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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Hospital General de Cuautitlan "General José Vicente Villada"
    Mexico City, 54800, Mexico
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Due to privacy and confidentiality restrictions, the data presented in this study is available on request from the corresponding author. The data are not publicly available due to the confidentiality restrictions of the Biosecurity, Ethics, and Research Committee of Hospital General de Cuatitlan "General José Vicente Villada"

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2024; primary completion for Feb 2025, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2024
First posted
Sep 19, 2024
StartEst.
Sep 9, 2024
Primary completionEst.
Feb 14, 2025
CompletionEst.
Feb 28, 2025
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06589973
Lead sponsor
Hospital General de Mexico
Responsible party
Christian Omar Ramos-Peñafiel, MD, PhD (Principal investigator, Hospital General de Mexico) — Principal investigator
First posted
Sep 19, 2024
Start date
Sep 9, 2024 (estimated)
Primary completion
Feb 14, 2025 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Christian O Ramos Peñafiel, PhD
Contact
leukemiachop33@gmail.com
5527892000 ext. 1420
Yossadara Hernández Ángeles, MD
Contact
yossadara.ha@gmail.com
5523351588

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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