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

NCT ID: NCT01865708

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-06-30

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.

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.

Conditions

Complication of Urinary Catheter

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Ethanol Lock

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ethanol; Dehydrated alcohol

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Healthcare of Atlanta

OTHER

Sponsor Role: lead

Responsible Party

Jana Stockwell

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jana A Stockwell, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Healthcare of Atlanta

Locations

Children's Helathcare of Atlanta at Egleston

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 26099520 (View on PubMed)

Other Identifiers

Ethanol Lock, Safety

Identifier Type: -

Identifier Source: org_study_id