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

Study Overview
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Brief Summary
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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.

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

Conditions
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Catheter Related Infections, Short Bowel Syndrome

Intervention / Treatment
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* Drug: 70% ethanol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Heparinized Saline<br>This group will maintain their central lines patent with heparinized saline. | Drug: 70% ethanol<br>* 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.<br>* Other names: ethanol lock;|
| Experimental: Ethanol lock solution group<br>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 | Drug: 70% ethanol<br>* 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.<br>* Other names: ethanol lock;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter related infections prevention/control, Anti infective agents, Catheter related infections prevention