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

Phase 2

Withdrawn

• Conditions: Catheter Related Infections; Short Bowel Syndrome
• Interventions: Drug: 70% ethanol

• Registration Number: NCT01263574
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-17
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-20
• Study Start: 2011-02
• Primary Completion: 2012-06
• Study Completion: 2012-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparinized Saline	70% ethanol	This group will maintain their central lines patent with heparinized saline.
Ethanol lock solution group	70% ethanol	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States