Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
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:
|
Outcome Measures
Primary Outcome Measures
- Blood Alcohol Level [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.
Secondary Outcome Measures
- Urine Analysis [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Helathcare of Atlanta at Egleston | Atlanta | Georgia | United States | 30329 |
Sponsors and Collaborators
- Children's Healthcare of Atlanta
Investigators
- Principal Investigator: Jana A Stockwell, MD, Children's Healthcare of Atlanta
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Ethanol Lock, Safety
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ethanol Lock |
|---|---|
| Arm/Group Description | 74% Ethanol lock will begin within 24 hours of urinary catheter placement. 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 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output. |
| Period Title: Overall Study | |
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Ethanol Lock |
|---|---|
| Arm/Group Description | 74% Ethanol lock will begin within 24 hours of urinary catheter placement. 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 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output. |
| Overall Participants | 10 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
6.7
(4.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
3
30%
|
| Male |
7
70%
|
Outcome Measures
| Title | Blood Alcohol Level |
|---|---|
| Description | 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. |
| Time Frame | up to 3 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of patients with detectable blood alcohol level, defined as >= 10 mg/dL. |
| Arm/Group Title | Ethanol Lock |
|---|---|
| Arm/Group Description | 74% Ethanol lock will begin within 24 hours of urinary catheter placement. 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 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output. |
| Measure Participants | 10 |
| Count of Participants [Participants] |
0
0%
|
| Title | Urine Analysis |
|---|---|
| Description | 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. |
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in detectable red blood cells per high powered field in urinalysis. 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. |
| Arm/Group Title | Ethanol Lock |
|---|---|
| Arm/Group Description | 74% Ethanol lock will begin within 24 hours of urinary catheter placement. 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 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output. |
| Measure Participants | 10 |
| Mean (Standard Deviation) [red blood cells per high powered field] |
90.1
(226.4)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Ethanol Lock | |
| Arm/Group Description | 74% Ethanol lock will begin within 24 hours of urinary catheter placement. 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 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output. | |
All Cause Mortality |
||
| Ethanol Lock | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Ethanol Lock | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/10 (40%) | |
| Renal and urinary disorders | ||
| Microscopic hematuria | 4/10 (40%) | 5 |
Other (Not Including Serious) Adverse Events |
||
| Ethanol Lock | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Jana Stockwell |
|---|---|
| Organization | Children's Healthcare of Atlanta |
| Phone | 404-785-1868 |
| jana.stockwell@choa.org |
- Ethanol Lock, Safety