Catheter Related Infections, Short Bowel Syndrome
Conditions
Keywords
Catheter related infections prevention/control, Anti infective agents, Catheter related infections prevention
Brief summary
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.
Interventions
DRUG70% 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.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter associated blood stream infection (CABSI). | 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. |
Countries
United States
Outcome results
None listed