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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

Tracking Information
First Submitted Date  ICMJE May 9, 2013
First Posted Date  ICMJE May 31, 2013
Results First Submitted Date  ICMJE August 1, 2016
Results First Posted Date  ICMJE April 2, 2018
Last Update Posted Date June 28, 2018
Study Start Date  ICMJE July 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
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.
Change History Complete list of historical versions of study NCT01865708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
Urine Analysis [ 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, for a total of 3 days. A baseline urinalysis will be obtained prior to the first instillation of ethanol.Looking for hematuria or increase in white blood cell count. A urinalysis will be obtained approximately1 hour after the lock was released.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Official Title  ICMJE Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Complication of Urinary Catheter
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Ethanol Lock
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01865708
Other Study ID Numbers  ICMJE Ethanol Lock, Safety
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jana Stockwell, Children's Healthcare of Atlanta
Study Sponsor  ICMJE Children's Healthcare of Atlanta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jana A Stockwell, MD Children's Healthcare of Atlanta
PRS Account Children's Healthcare of Atlanta
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP