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

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
Recruitment Status : Completed
First Posted : May 31, 2013
Results First Posted : April 2, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jana Stockwell, Children's Healthcare of Atlanta

Study Description
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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
Complication of Urinary Catheter Drug: Ethanol Lock 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
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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
Arms and Interventions
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Arm Intervention/treatment
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:
  • Ethanol
  • Dehydrated alcohol


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

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


Locations
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United States, Georgia
Children's Helathcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
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Principal Investigator: Jana A Stockwell, MD Children's Healthcare of Atlanta
More Information
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Publications of Results:

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Responsible Party: Jana Stockwell, M.D., Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT01865708    
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jana Stockwell, Children's Healthcare of Atlanta:
Ethanol Lock
Alcohol lock
Urinary catheter
Safety
Additional relevant MeSH terms:
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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