Your session is about to expire
← Back to Search
Benzodiazepine
Phenobarbital based treatment for Alcohol Withdrawal (PARTI Trial)
Phase 4
Waitlist Available
Led By Bhagat Aulakh, MD
Research Sponsored by OSF Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study completion, up to 18 months
Awards & highlights
PARTI Trial Summary
This trial is comparing two different protocols for treating patients with alcohol withdrawal syndrome who haven't responded to benzodiazepines.
Eligible Conditions
- Alcohol Withdrawal
- Alcohol Withdrawal Syndrome
PARTI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study completion, up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study completion, up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ICU length of stay
Secondary outcome measures
30-day readmission
Hospital length of stay
Hospitalization cost
+5 morePARTI Trial Design
2Treatment groups
Active Control
Group I: Phenobarbital based treatmentActive Control1 Intervention
The phenobarbital group will undergo management with a phenobarbital based treatment protocol with additional symptom triggered therapies.
On day 1, the phenobarbital group receive a loading dose of phenobarbital intravenous 10mg/kg (actual body weight) with a maximum dose of 1 g/100 mL
On day 2 of study protocol, and no sooner than 12 hours after loading dose, phenobarbital 64.8 mg is administered every 12 hours for two doses.
On day 3 of study protocol, patients will receive phenobarbital 32.4 mg every 12 hours for two doses.
On day 4 of study protocol, patients will receive phenobarbital 32.4 mg once, to be given 24 hours after last scheduled dose.
Throughout the 4 day protocol, the patient will have phenobarbital 65 mg every 6 hours as needed available either IM or IV, starting no sooner than 30 minutes after the loading dose.
Group II: Lorazepam based treatmentActive Control1 Intervention
The lorazepam group will undergo management with a lorazepam based treatment protocol with additional symptom triggered therapies.
On Day 1, the lorazepam group will be started on scheduled lorazepam 4 mg every 6 hours
After day 1, the scheduled lorazepam dose will be modified based on the total lorazepam requirements from the previous day and divided into 4-6 doses.
A lorazepam infusion, at physician discretion, will be available at any point if the dose of scheduled and PRN lorazepam being given is too high or frequent to effectively be administered.
Once symptoms are well controlled on lorazepam based therapy, the total dose given over the past 24 hours will be calculated and weaned by approximately 10-20% per day when clinically appropriate.
Throughout the entire protocol, 2-4 mg lorazepam IV q 30 minutes PRN will be available for a goal CIWA <6 or RASS -1 to 0.
Find a Location
Who is running the clinical trial?
OSF Healthcare SystemLead Sponsor
29 Previous Clinical Trials
33,534 Total Patients Enrolled
Bhagat Aulakh, MD3.45 ReviewsPrincipal Investigator - OSF Healthcare System
OSF Healthcare System
5Patient Review
He is very knowledgable and understands medicine. I understood what he discussed with me and I felt comfortable with those decisions.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger