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

Primary Purpose

Catheter Related Infections, Short Bowel Syndrome

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
70% ethanol
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter Related Infections focused on measuring Catheter related infections prevention/control, Anti infective agents, Catheter related infections prevention

Eligibility Criteria

3 Months - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Heparinized Saline

Ethanol lock solution group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2010
Last Updated
June 20, 2017
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01263574
Brief Title
Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome
Official Title
Trial of Ethanol Lock Therapy to Prevent Catheter Associated Blood Stream Infections
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No participants. IND denied by FDA.
Study Start Date
February 2011 (Anticipated)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Related Infections, Short Bowel Syndrome
Keywords
Catheter related infections prevention/control, Anti infective agents, Catheter related infections prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heparinized Saline
Arm Type
Placebo Comparator
Arm Description
This group will maintain their central lines patent with heparinized saline.
Arm Title
Ethanol lock solution group
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
70% ethanol
Other Intervention Name(s)
ethanol lock
Intervention Description
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.
Primary Outcome Measure Information:
Title
Catheter associated blood stream infection (CABSI).
Description
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.
Time Frame
Number of infections reported per 1000 catheter days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Jaksic, M.D, Ph.D
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Duggan, M.D, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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