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

Purpose

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.

Condition	Intervention	Phase
Catheter Related Infections Short Bowel Syndrome	Drug: 70% ethanol	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention

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MedlinePlus related topics: Blood Thinners

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

Catheter associated blood stream infection (CABSI). [ Time Frame: Number of infections reported per 1000 catheter days. ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	48
Study Start Date:	February 2011
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Heparinized Saline This group will maintain their central lines patent with heparinized saline.	Drug: 70% ethanol Administration of the 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. The pre-measured volume of lock solution will then be injected into the catheter. The minimum dwell time of 4 hours will follow. 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. On the other four days of the week, patients will receive heparin locks, per current standard of care. Volume of lock solution administered will be determined by catheter size.
Experimental: Ethanol lock solution group Administration of the 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 Administration of the 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. The pre-measured volume of lock solution will then be injected into the catheter. The minimum dwell time of 4 hours will follow. 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. On the other four days of the week, patients will receive heparin locks, per current standard of care. Volume of lock solution administered will be determined by catheter size.

Arms

Assigned Interventions

Placebo Comparator: Heparinized Saline

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

Drug: 70% ethanol

Administration of the 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. The pre-measured volume of lock solution will then be injected into the catheter. The minimum dwell time of 4 hours will follow. 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. On the other four days of the week, patients will receive heparin locks, per current standard of care. Volume of lock solution administered will be determined by catheter size.

Experimental: Ethanol lock solution group

Administration of the 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

Administration of the 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. The pre-measured volume of lock solution will then be injected into the catheter. The minimum dwell time of 4 hours will follow. 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. On the other four days of the week, patients will receive heparin locks, per current standard of care. Volume of lock solution administered will be determined by catheter size.

Eligibility

Ages Eligible for Study:	3 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263574

Contacts

Contact: Tom Jaksic, M.D, Ph.D	617 355 9600
Contact: Christopher Duggan, M.D, MPH	617 355 9600

Locations

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Children's Hospital Boston

Investigators

Principal Investigator:	Tom Jaksic, M.D, Ph.D	Children's Hospital Boston
Principal Investigator:	Christopher Duggan, M.D, MPH	Children's Hospital Boston

More Information

No publications provided

Responsible Party:	Tom Jaksic, M.D, Ph.D, W. Hardy Hendren Professor of Surgery Surgical Director, Center for Advanced Intestinal Rehabilitation Vice-Chairman of Pediatric Surgery, Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT01263574 History of Changes
Other Study ID Numbers:	09-03-0132
Study First Received:	December 17, 2010
Last Updated:	December 28, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Hospital Boston:

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

Additional relevant MeSH terms:

Short Bowel Syndrome
Catheter-Related Infections
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Infection

Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013