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NCT01865708 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
A Phase 1 study of Complication of Urinary Catheter, sponsored by Children's Healthcare of Atlanta.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01865708: Completed Phase 1 study of Complication of Urinary Catheter, sponsored by Children's Healthcare of Atlanta.
NCT01865708 is a Phase 1 study of Complication of Urinary Catheter that has completed, run by Children's Healthcare of Atlanta. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01865708, a Phase 1 study of Complication of Urinary Catheter, has completed, sponsored by Children's Healthcare of Atlanta.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour. Blood alcohol levels will be obtained every day, approximately 1 hour after ethanol lock release, for 3 days: at baseline, 1 day post catheter placement, 2 days post catheter placement, and 3 days post catheter placement. Number of participants with Blood Alcohol Levels exceeding 10 mg/100 ml on any study day was analyzed.
Conditions Studied
Interventions
- DRUG Ethanol Lock
Study Locations (1)
Georgia
- Children's Helathcare of Atlanta at Egleston - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT01865708 record still lists
NCT01865708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Complication of Urinary Catheter appearing as the primary indexed condition, and to 1 intervention - of which Ethanol Lock is the first listed.
NCT01865708 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01865708 about?
NCT01865708 is a clinical study titled "Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children". 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.
What is the current status of trial NCT01865708?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-07. Estimated completion is 2015-06.
What conditions does trial NCT01865708 study?
This clinical trial studies the following conditions: Complication of Urinary Catheter.
What interventions are being tested in trial NCT01865708?
The interventions under investigation include: Ethanol Lock (DRUG).
Who is sponsoring clinical trial NCT01865708?
This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01865708 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01865708's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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