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Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01472965
First Posted: November 17, 2011
Last Update Posted: November 13, 2017
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.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
Results First Submitted: August 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Central Line-Associated Bloodstream Infection
Interventions: Drug: ethanol
Drug: heparin-saline placebo

  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
Participants meeting eligibility criteria were enrolled between December 2011 and August 2016. They were randomized to receive catheter lock therapy using either 70% ethanol or heparin-saline (placebo). Randomization was blinded to the participant, their care provider, the investigator, and the outcomes assessor.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Ethanol)

Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.

ethanol: 70% ethanol catheter lock therapy

Control (Placebo)

Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.

heparin-saline placebo: heparin-saline placebo catheter lock therapy


Participant Flow:   Overall Study
    Treatment (Ethanol)   Control (Placebo)
STARTED   49   46 
COMPLETED   48   46 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  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.
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Reporting Groups
  Description
Treatment (Ethanol)

Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.

ethanol: 70% ethanol catheter lock therapy

Control (Placebo)

Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.

heparin-saline placebo: heparin-saline placebo catheter lock therapy

Total Total of all reporting groups

Baseline Measures
   Treatment (Ethanol)   Control (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   46   94 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.8  (6.3)   8.3  (6.7)   8.6  (6.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   14   21   35 
Male   34   25   59 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   8   8   16 
Not Hispanic or Latino   35   36   71 
Unknown or Not Reported   5   2   7 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   1   0   1 
Asian   2   1   3 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   6   12   18 
White   31   30   61 
More than one race   4   1   5 
Unknown or Not Reported   3   2   5 
Region of Enrollment 
[Units: Participants]
     
United States   42   45   87 
Australia   6   1   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Therapeutic Failures (Early or Late Failure) in Children and Adolescents With CLABSI Receiving Standard Care Plus Ethanol Lock Therapy (ELT) vs. Standard Care Alone   [ Time Frame: Up to 25 weeks after the start of treatment. ]

2.  Secondary:   Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone   [ Time Frame: Up to 25 weeks after the start of treatment ]

3.  Secondary:   Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone   [ Time Frame: Up to 25 weeks after the start of treatment ]

4.  Secondary:   Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone   [ Time Frame: Up to 25 weeks after the start of treatment. ]

5.  Secondary:   Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone   [ Time Frame: Up to 26 weeks after the start of treatment. ]

6.  Secondary:   Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone   [ Time Frame: Up to 37.5 weeks after the start of treatment. ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joshua Wolf, MBBS, BA
Organization: St. Jude Children's Research Hospital
phone: 901-595-1475
e-mail: joshua.wolf@stjude.org



Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01472965     History of Changes
Other Study ID Numbers: ETHEL
First Submitted: November 14, 2011
First Posted: November 17, 2011
Results First Submitted: August 18, 2017
Results First Posted: November 13, 2017
Last Update Posted: November 13, 2017