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

NCT01263574 | Withdrawn Phase 2 DMC

• 1 other identifier: 09-03-0132
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Related Infections; Short Bowel Syndrome

Keywords

Catheter related infections prevention/control; Anti infective agents; Catheter related infections prevention

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Heparinized Saline

PLACEBO COMPARATOR

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

Drug: 70% ethanol

Ethanol lock solution group

EXPERIMENTAL

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

Interventions

70% ethanol 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.

Also known as: ethanol lock

Ethanol lock solution group; Heparinized Saline

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>3 months
• Intestinal failure patients
• Silicone catheter for the administration of parenteral nutrition

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Catheter-Related Infections; Short Bowel Syndrome

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Infections; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Tom Jaksic, M.D, Ph.D

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Christopher Duggan, M.D, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: W. Hardy Hendren Professor of Surgery, Harvard Medical School

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 20, 2010
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)