Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01865708 |
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Recruitment Status :
Completed
First Posted : May 31, 2013
Results First Posted : April 2, 2018
Last Update Posted : June 28, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Complication of Urinary Catheter | Drug: Ethanol Lock | Phase 1 |
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 blood alcohol levels after a 1 hour 74% ethanol lock in urinary catheters utilized in the Pediatric Intensive Care Unit.
Specific Aim 2:
Compare cellular components in urinalyses after the introduction of the ethanol locks.
Potential study subjects will be recruited from the Children's Healthcare of Atlanta - Egleston Pediatric Intensive Care Unit. Children that are anticipated to have an indwelling urinary catheter for >48 hours will be included. For this pilot study, the investigators will enroll 10 patients. Subject ages will range from 6 months to 17 years. Children who are on a service other than Critical Care Medicine will have clearance from the primary team prior to approaching for enrollment. The consent process will take place prior to or during the initial 24 hours of urinary catheter placement.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children |
| Study Start Date : | July 2013 |
| Actual Primary Completion Date : | November 2013 |
| Actual Study Completion Date : | June 2015 |
| Arm | Intervention/treatment |
|---|---|
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Ethanol lock
Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.
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Drug: Ethanol Lock
Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.
Other Names:
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- Blood Alcohol Level [ Time Frame: up to 3 days ]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.
- Urine Analysis [ Time Frame: Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-EL days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any EL. ]
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, for a total of 3 days.
A baseline urinalysis will be obtained prior to the first instillation of ethanol, looking for hematuria.
A urinalysis will be obtained approximately 1 hour after the lock is released. Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-ethanol lock days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any ethanol lock.
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| Ages Eligible for Study: | 6 Months to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865708
| United States, Georgia | |
| Children's Helathcare of Atlanta at Egleston | |
| Atlanta, Georgia, United States, 30329 | |
| Principal Investigator: | Jana A Stockwell, MD | Children's Healthcare of Atlanta |
Publications of Results:
| Responsible Party: | Jana Stockwell, M.D., Children's Healthcare of Atlanta |
| ClinicalTrials.gov Identifier: | NCT01865708 History of Changes |
| Other Study ID Numbers: |
Ethanol Lock, Safety |
| First Posted: | May 31, 2013 Key Record Dates |
| Results First Posted: | April 2, 2018 |
| Last Update Posted: | June 28, 2018 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ethanol Lock Alcohol lock Urinary catheter Safety |
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Critical Illness Disease Attributes Pathologic Processes Ethanol |
Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |