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

Short Bowel Syndrome Clinical Trial

Official title:

Trial of Ethanol Lock Therapy to Prevent Catheter Associated Blood Stream Infections

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01263574
• Other study ID #: 09-03-0132
• Status: Withdrawn
• Phase: Phase 2
• First received: December 17, 2010
• Last updated: June 20, 2017
• Start date: February 2011
• Est. completion date: September 2012

Study information

• Verified date: June 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Infections
• Catheter-Related Infections
• Communicable Diseases
• Infection
• Short Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter associated blood stream infection (CABSI).	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.	Number of infections reported per 1000 catheter days.