Phase 1
N=10
Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Complication of Urinary Catheter
Bottom Line
View on ClinicalTrials.gov: NCT01865708 ↗Enrolled (actual)
10
Serious AEs
40.0%
Results posted
Apr 2018
Primary outcome: Primary: Blood Alcohol Level — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ethanol Lock (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Healthcare of Atlanta
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Alcohol Level |
— | — |
| SECONDARY Urine Analysis |
90.1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01865708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.