Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children

NCT01865708 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: Ethanol Lock, Safety
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis 1: Blood alcohol concentration will be \<25 mg/100ml (equivalent to a blood alcohol concentration of \<0.025%) after a 1 hour urinary catheter ethanol lock. Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or increased urinary white cells.

Conditions

Complication of Urinary Catheter

Keywords

Ethanol Lock; Alcohol lock; Urinary catheter; Safety

Outcome Measures

Primary Outcomes (1)

• Blood Alcohol Level

  An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour. Blood alcohol levels will be obtained every day, approximately 1 hour after ethanol lock release, for 3 days: at baseline, 1 day post catheter placement, 2 days post catheter placement, and 3 days post catheter placement. Number of participants with Blood Alcohol Levels exceeding 10 mg/100 ml on any study day was analyzed.

  up to 3 days

Secondary Outcomes (1)

• Urine Analysis

  Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-EL days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any EL.

Study Arms (1)

Ethanol lock

OTHER

Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.

Drug: Ethanol Lock

Interventions

Ethanol Lock DRUG

Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.

Also known as: Ethanol, Dehydrated alcohol

Ethanol lock

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 6 months - 17 years
• Urinary catheter placed at Children's Healthcare of Atlanta
• Anticipated urinary catheter need for \> 48 hours
• Parent or legal guardian (or patient when applicable) consent for enrollment.

You may not qualify if:

• yo or older.
• Urosepsis at time of study enrollment
• Known bladder or genitourinary abnormalities
• Chronic bladder drainage regimen
• Urologic surgeries (as part of the current admission)
• Medical urgency preventing timely administration of the consenting process, or any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
• Anuria or oliguria (\<0.5 cc/kg/hr averaged over the previous 12 hours)
• Other technical considerations that would prevent the timely acquisition of sufficient samples such as (but not limited to) absence of a study team member.
• Parent or legal guardian (or patient when applicable) refuses to sign informed consent.

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Helathcare of Atlanta at Egleston

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• Teppa BE, Stockwell JA. Safety of daily ethanol locks for urinary catheters in critically ill children: a pilot study. Am J Infect Control. 2015 Oct 1;43(10):1114-5. doi: 10.1016/j.ajic.2015.05.012. Epub 2015 Jun 19.

  PMID: 26099520 RESULT

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Jana Stockwell
• Organization: Children's Healthcare of Atlanta

jana.stockwell@choa.org

404-785-1868

Study Officials

• Jana A Stockwell, MD

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 31, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: June 1, 2015
• Last Updated: June 28, 2018
• Results First Posted: April 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)