Clinical trial NCT01865708: Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Official title: Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Complication of Urinary Catheter
Keywords: Ethanol Lock
Alcohol lock
Urinary catheter
Safety
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Blood Alcohol Level
timeFrame: up to 3 days
Secondary outcomes:
measure: Urine Analysis
timeFrame: 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.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Helathcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Jana A Stockwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.