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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Healthcare of Atlanta
• Treatments: Ethanol

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.