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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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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Complication of Urinary Catheter
Intervention Drug: Ethanol Lock
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ethanol Lock
Hide 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
Arm/Group Title Ethanol Lock
Hide 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 Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
6.7  (4.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
1.Primary Outcome
Title Blood Alcohol Level
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with detectable blood alcohol level, defined as >= 10 mg/dL.
Arm/Group Title Ethanol Lock
Hide 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 Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Urine Analysis
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: red blood cells per high powered field
90.1  (226.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ethanol Lock
Hide 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ethanol Lock
Affected / at Risk (%) # Events
Total   4/10 (40.00%)    
Renal and urinary disorders   
Microscopic hematuria  [1]  4/10 (40.00%)  5
Indicates events were collected by systematic assessment
[1]
Microscopic hematuria (>100 RBC/HPF) detected by lab analysis of urine specimen.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ethanol Lock
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Dr. Jana Stockwell
Organization: Children's Healthcare of Atlanta
Phone: 404-785-1868
EMail: jana.stockwell@choa.org
Layout table for additonal information
Responsible Party: Jana Stockwell, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT01865708     History of Changes
Other Study ID Numbers: Ethanol Lock, Safety
First Submitted: May 9, 2013
First Posted: May 31, 2013
Results First Submitted: August 1, 2016
Results First Posted: April 2, 2018
Last Update Posted: June 28, 2018