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Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome

This study has been withdrawn prior to enrollment.
(No participants. IND denied by FDA.)
Sponsor:
Information provided by (Responsible Party):
Tom Jaksic, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT01263574
First received: December 17, 2010
Last updated: June 20, 2017
Last verified: June 2017
December 17, 2010
June 20, 2017
February 2011
June 2012   (Final data collection date for primary outcome measure)
Catheter associated blood stream infection (CABSI). [ Time Frame: Number of infections reported per 1000 catheter days. ]
Published data in intensive care unit (ICU) patients with CABSI has noted that central venous catheter cultures had a specificity of 98% and a negative predictive value of 97%. In our study, we will define CABSI as a positive central venous catheter blood culture in the face of clinical signs of infection, when the catheter has been used in the last 48 hours prior to infection, and without other obvious source of infection. CABSI rate will be reported as number of infections per 1000 catheter days after 12 months of follow up.
Catheter associated blood stream infection (CABSI). [ Time Frame: Number of infections reported per 1000 catheter days. ]
Published data in ICU patients with CABSI has noted that central venous catheter cultures had a specificity of 98% and a negative predictive value of 97%. In our study, we will define CABSI as a positive central venous catheter blood culture in the face of clinical signs of infection, when the catheter has been used in the last 48 hours prior to infection, and without other obvious source of infection. CABSI rate will be reported as number of infections per 1000 catheter days after 12 months of follow up.
Complete list of historical versions of study NCT01263574 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome
Trial of Ethanol Lock Therapy to Prevent Catheter Associated Blood Stream Infections
This study is designed to determine if the use of 70% ethanol lock solution in central lines decreases the rate of central line infections in children with short bowel syndrome. While ethanol locks have been used safely in children, there has been no published research to date that clearly shows it is of definite benefit in this group of patients.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Prevention
  • Catheter Related Infections
  • Short Bowel Syndrome
Drug: 70% ethanol
Administration of the lock solution will occur between cycles of parenteral nutrition. Lock solutions will be administered three days per week. The pre-measured volume of lock solution will then be injected into the catheter for 4 hours. Prior to the next instillation of medications into the catheter, the lock solution will be aspirated and discarded. Another 5mL flush of saline will then be instilled into the catheter prior to medication or parenteral nutrition administration. Volume of lock solution administered will be determined by catheter size.
Other Name: ethanol lock
  • Placebo Comparator: Heparinized Saline
    This group will maintain their central lines patent with heparinized saline.
    Intervention: Drug: 70% ethanol
  • Experimental: Ethanol lock solution group
    Administration of the 70% ethanol lock solution will occur between cycles of parenteral nutrition. Randomized lock solutions will be administered three days per week. When patients have completed their parenteral nutrition, their central venous catheters will be flushed with 5mL saline, per current standards
    Intervention: Drug: 70% ethanol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age >3 months
  • Intestinal failure patients
  • Silicone catheter for the administration of parenteral nutrition

Exclusion Criteria:

  • Age < 3 months
  • Weight < 5 kg
  • Documented allergy to ethanol
  • Evidence of tunnel site infection
  • Patients receiving continuous renal replacement therapy
  • Concomitant use of metronidazole
Sexes Eligible for Study: All
3 Months and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01263574
09-03-0132
Yes
Not Provided
No
Not Provided
Tom Jaksic, Boston Children's Hospital
Boston Children’s Hospital
Not Provided
Principal Investigator: Tom Jaksic, M.D, Ph.D Boston Children’s Hospital
Principal Investigator: Christopher Duggan, M.D, MPH Boston Children’s Hospital
Boston Children’s Hospital
June 2017

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