Status:
COMPLETED
Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Lead Sponsor:
Children's Healthcare of Atlanta
Conditions:
Complication of Urinary Catheter
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
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 cat...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01865708
Start Date
July 1 2013
End Date
June 1 2015
Last Update
June 28 2018
Active Locations (1)
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1
Children's Helathcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30329