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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-09-30

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.

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Detailed Description

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Conditions

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Catheter Related Infections Short Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Heparinized Saline

This group will maintain their central lines patent with heparinized saline.

Group Type PLACEBO_COMPARATOR

70% ethanol

Intervention Type DRUG

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.

Ethanol lock solution group

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

Group Type EXPERIMENTAL

70% ethanol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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ethanol lock

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

Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes