Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 6/30/2018 |
| Start Date: | July 2013 |
| End Date: | June 2015 |
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.
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.
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.
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.
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.
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