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

Boston Children's Hospital

Status and phase: Withdrawn; Phase 2

Conditions: Catheter Related Infections; Short Bowel Syndrome

Treatments: Drug: 70% ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT01263574

09-03-0132

Details and patient eligibility

About

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.

Sex: All

Ages: 3+ months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Heparinized Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: 70% ethanol

Ethanol lock solution group

Experimental group

Description:

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

Treatment:

Drug: 70% ethanol