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

Primary Purpose

Complication of Urinary Catheter

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ethanol Lock
Sponsored by
Children's Healthcare of Atlanta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Complication of Urinary Catheter focused on measuring Ethanol Lock, Alcohol lock, Urinary catheter, Safety

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Helathcare of Atlanta at Egleston

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ethanol lock

Arm Description

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.

Outcomes

Primary Outcome Measures

Blood Alcohol Level
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
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.

Full Information

First Posted
May 9, 2013
Last Updated
April 18, 2018
Sponsor
Children's Healthcare of Atlanta
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1. Study Identification

Unique Protocol Identification Number
NCT01865708
Brief Title
Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Official Title
Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Healthcare of Atlanta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Urinary Catheter
Keywords
Ethanol Lock, Alcohol lock, Urinary catheter, Safety

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethanol lock
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ethanol Lock
Other Intervention Name(s)
Ethanol, Dehydrated alcohol
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jana A Stockwell, MD
Organizational Affiliation
Children's Healthcare of Atlanta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Helathcare of Atlanta at Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26099520
Citation
Teppa BE, Stockwell JA. Safety of daily ethanol locks for urinary catheters in critically ill children: a pilot study. Am J Infect Control. 2015 Oct 1;43(10):1114-5. doi: 10.1016/j.ajic.2015.05.012. Epub 2015 Jun 19.
Results Reference
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Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children

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