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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Children's Hospital Boston.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01263574
First received: December 17, 2010
Last updated: December 28, 2010
Last verified: December 2010

December 17, 2010
December 28, 2010
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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
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Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome
Not Provided

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: Double Blind (Subject, Caregiver, 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. 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. The pre-measured volume of lock solution will then be injected into the catheter. The minimum dwell time of 4 hours will follow. 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. On the other four days of the week, patients will receive heparin locks, per current standard of care. Volume of lock solution administered will be determined by catheter size.
  • 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 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.
 
Not yet recruiting
48
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
Both
3 Months and older
Yes
Contact: Tom Jaksic, M.D, Ph.D 617 355 9600
Contact: Christopher Duggan, M.D, MPH 617 355 9600
United States
 
NCT01263574
09-03-0132
Yes
Tom Jaksic, M.D, Ph.D, W. Hardy Hendren Professor of Surgery Surgical Director, Center for Advanced Intestinal Rehabilitation Vice-Chairman of Pediatric Surgery, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Tom Jaksic, M.D, Ph.D Children's Hospital Boston
Principal Investigator: Christopher Duggan, M.D, MPH Children's Hospital Boston
Children's Hospital Boston
December 2010

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