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Pediatric Ethanol Lock Therapy Study.

This study has been completed.
Information provided by (Responsible Party):
Judy Martin, University of Pittsburgh Identifier:
First received: July 7, 2009
Last updated: March 18, 2016
Last verified: March 2016
Results First Received: February 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Catheter-Related Infections
Interventions: Drug: 25% ethanol
Other: heparin lock

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Children at our hospital with central venous access for parental nutrition and at least 3 CRBSI in the past 6 months were recruited. Patients had to be at least 6 months old and <21 years and be able to have a minimal dwell time of 4 hours. Exclusion criteria: known immunodeficiency or allergies to ethanol or heparin.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomized to one of two study groups. group 1 - ethanol lock followed by washout period followed by heparin lock. group 2 - heparin lock followed by washout period followed by ethanol lock.

Reporting Groups
25% Ethanol/Washout/Heparin First 25% ethanol, then Washout, then heparin
Heparin Lock/Washout/25% Ethanol First Heparin lock, then washout period, then 25% ethanol lock

Participant Flow:   Overall Study
    25% Ethanol/Washout/Heparin   Heparin Lock/Washout/25% Ethanol
STARTED   8   8 
COMPLETED   7   4 
no longer meet inclusion criteria                1                4 

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Children meeting the inclusion and exclusion criteria who received care at Children's Hospital of Pittsburgh were enrolled.

Reporting Groups
Group 1 25% ethanol x12 weeks; washout x4 weeks; heparin x12 weeks
Group 2 Heparin x12 weeks; washout x4 weeks; 25% ethanol x 12 weeks
Total Total of all reporting groups

Baseline Measures
    Group 1   Group 2   Total
Overall Participants 
[units: participants]
 7   4   11 
[units: years]
Mean (Full Range)
 (1.2 to 13.5) 
 (1.3 to 2.6) 
 (1.2 to 13.5) 
[units: participants]
Female   4   1   5 
Male   3   3   6 
Race (NIH/OMB) 
[units: participants]
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   3   2   5 
White   4   2   6 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[units: participants]
United States   7   4   11 

  Outcome Measures
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1.  Primary:   Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period.   [ Time Frame: 7 months per study patient ]

2.  Secondary:   Safety, Side Effects   [ Time Frame: 7 months per study patient ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Judith M. Martin, MD
Organization: University of Pittsburgh
phone: 412-692-7028

Responsible Party: Judy Martin, University of Pittsburgh Identifier: NCT00948441     History of Changes
Other Study ID Numbers: 08010189
Study First Received: July 7, 2009
Results First Received: February 19, 2016
Last Updated: March 18, 2016
Health Authority: United States: Institutional Review Board