Alcohol Withdrawal SyndromeNCT06589973
Effect of Clinical and Biochemical Variables Over Morbidity and Mortality in Alcohol Withdrawal Syndrome Patients
An observational study of Alcohol Withdrawal Syndrome, run by Hospital General de Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcohol Withdrawal Syndrome
- What is being tested?
- Study Cohort
- How many people
- 195 participants
- Where
- 1 siteMexico
- Study dates
- 9 Sep 2024to 28 Feb 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de Cuautitlan "General José Vicente Villada"
Mexico City, 54800
Yossadara Hernández Ángeles, MD, 55 5872 1754, yossadara.ha@gmail.com
About this study
Official 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"
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?
Read more
- 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.
- Conditions
- Alcohol Withdrawal Syndrome
- Being tested
- Study Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study CohortOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Permanent cessation of all vital functions of an organism, including irreversible stopping of the heart and breathing
Measured: 6 months
Morbidity
Any type of complication present during the analysis period that complicates the resolution of the condition, including serious situations.
Measured: 6 months
Secondary outcomes (2)
Hospital stay
Time recorded in the clinical record of the duration of symptoms from the first clinical manifestation until the time of discharge.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Sep 2024 (estimated)
- Primary completion14 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 195 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589973
- Sponsor's protocol ID
- 606023-01-1624
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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"
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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"
- ClinicalTrials.gov ID
- NCT06589973
- Acronym / sponsor ID
- 606023-01-1624
- Conditions
- Alcohol Withdrawal Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 9 Sep 2024 (estimated)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study CohortClinical 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. | Other | – |
Primary outcome
Death
Time frame: 6 months
Permanent cessation of all vital functions of an organism, including irreversible stopping of the heart and breathing
Morbidity
Time frame: 6 months
Any type of complication present during the analysis period that complicates the resolution of the condition, including serious situations.
2 secondary outcomes
Hospital stay
Time frame: 6 months
Duration of symptoms
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: 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"
Related trials for Alcohol Withdrawal Syndrome
RecruitingPhase 2/3
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Withdrawal
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruiting
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
Intoxication, Delirium Tremens (DTs)
Not yet recruiting
Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal
Cognitive Cycling, Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Withdrawal Syndrome, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian O Ramos Peñafiel, PhD (5527892000 ext. 1420, leukemiachop33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.