Metabolism of Chlordiazepoxide in the Treatment of Alcohol Withdrawal Symptoms

NCT05563350 | Completed DMC FDA Drug

• 1 other identifier: KLOPOXID2021
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to elucidate if CYP-phenotypes, variations in CYP-genotypes and dose of chlordiazepoxide is correlated to chlordiazepoxide plasma concentrations in patients admitted to Intensive Care or High Dependency Units due to either respiratory insufficiency and/or agitation while treated for alcohol withdrawal symptoms.

Conditions

Alcohol Withdrawal

Keywords

ICU; Intensive care; CYP3A4; CYP2C19; Chlordiazepoxide

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of chlordiazepoxide and metabolites

  p-chlordiazepoxide and metabolites.

  At inclusion and 12 hours after inclusion

Secondary Outcomes (4)

• Half-life (T½) for chlordiazepoxide

  At inclusion and 12 hours after inclusion

• Cumulative dose of chlordiazepoxide before admission to ICU/HDU

  From date of hospital admittance until the date of inclusion in the study no later than 12 hours after admission on either ICU or HDU

• ICU/HDU and hospital length of stay (LOS) within 90 days

  90 days after ICU admission and 90 days after hospital admission

• Need for mechanical ventilation within 90 days

  90 days after inclusion

Interventions

Blood samples DIAGNOSTIC_TEST

p-chlordiazepoxide and metabolites, p-omeprazole and metabolites, p-midazolam and metabolites, CYP3A4 and CYP2C19 genotyping

Also known as: Midazolam and omeprazole as pharmacological probes

Eligibility Criteria

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

Study Population

26 consecutive patients will be included no later than 12 h after ICU or HDU admission after treatment with moderate or large doses (minimum dose 200 mg independently of body weight) of chlordiazepoxide for alcohol withdrawal symptoms.

You may qualify if:

• Age ≥18 years
• Treatment with minimum 200 mg chlordiazepoxide for alcohol withdrawal symptoms during hospital admission
• Acute admittance to ICU or HDU due to respiratory insufficiency, impaired consciousness or agitation.

You may not qualify if:

• Allergies to omeprazole/esomeprazole and midazolam
• Treatment with midazolam within 1 day prior to ICU/HDU admission
• Cardiac arrest prior to admission

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Bispebjerg and Frederiksberg Hospital

Copenhagen, 2400, Denmark

Location

Biospecimen

Retention: NONE RETAINED

Blood samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nanna Reiter, MD

  Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: October 3, 2022
• Study Start: January 29, 2022
• Primary Completion: June 11, 2023
• Study Completion: July 1, 2023
• Last Updated: May 7, 2024

Record last verified: 2022-09

Locations

DK (1)