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

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.

Study Overview

• Status: Completed
• Conditions: Complication of Urinary Catheter
• Intervention / Treatment: Drug: Ethanol Lock

Detailed Description

This study involves a confirmatory/refuting approach to the above stated hypothesis. The investigators will test this hypothesis by addressing the following aims/objectives:

Specific Aim 1:

Quantify blood alcohol levels after a 1 hour 74% ethanol lock in urinary catheters utilized in the Pediatric Intensive Care Unit.

Specific Aim 2:

Compare cellular components in urinalyses after the introduction of the ethanol locks.

Potential study subjects will be recruited from the Children's Healthcare of Atlanta - Egleston Pediatric Intensive Care Unit. Children that are anticipated to have an indwelling urinary catheter for >48 hours will be included. For this pilot study, the investigators will enroll 10 patients. Subject ages will range from 6 months to 17 years. Children who are on a service other than Critical Care Medicine will have clearance from the primary team prior to approaching for enrollment. The consent process will take place prior to or during the initial 24 hours of urinary catheter placement.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Helathcare of Atlanta at Egleston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 18 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Ethanol lock; 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; 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.; Other Names: Ethanol; Dehydrated alcohol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Analysis	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, for a total of 3 days. A baseline urinalysis will be obtained prior to the first instillation of ethanol, looking for hematuria. A urinalysis will be obtained approximately 1 hour after the lock is released. Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-ethanol lock days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any ethanol lock.	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.

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Jana A Stockwell, MD, Children's Healthcare of Atlanta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 9, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Ethanol Lock; Alcohol lock; Urinary catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: Ethanol Lock, Safety

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No