Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children

Completed · Phase 1

Conditions studied: Complication of Urinary Catheter

In brief

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.

Key facts

Study ID

NCT01865708

Run by

Children's Healthcare of Atlanta

People needed

10

Starts

2013-07-01

Expected to finish

2015-06-01

Last updated by the study team

2018-06-28

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Helathcare of Atlanta at Egleston — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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