NCT01652326

Brief Summary

The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
792

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

3.2 years

First QC Date

July 20, 2012

Last Update Submit

January 12, 2016

Conditions

Alcohol Withdrawal Syndrome

Outcome Measures

Primary Outcomes (1)

  • Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome

    up to 38 months

Secondary Outcomes (3)

  • Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome

    Up to 38 months

  • Effectiveness of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal

    Up to 38 months

  • Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal

    Up to 38 months

Study Arms (1)

Benzodiazepine-resistant

those patients with either 1) a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs; 2) \>40mg of diazepam (or diazepam equivalents) in 1 hr; or 3) an individual dose of 40 mg or greater of intravenous diazepam for control of agitation

Drug: Diazepam

Interventions

DiazepamDRUG
Benzodiazepine-resistant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospitalized inpatients

You may qualify if:

  • either
  • a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs;
  • \> 40mg of diazepam (or diazepam equivalents) in 1 hr; or
  • an individual dose of 40 mg or greater of intravenous diazepam for control of agitation

You may not qualify if:

  • if \< 18 years of age or had evidence of use of other illicit substances as determined by urine toxicology screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Diazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 30, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

US(1)