Evaluation of the Clinical Practice of Using of a 70% Ethanol Lock Solution for the Prevention of Catheter Related Blood Stream Infections in Pediatric Patients Undergoing Intestinal Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01409772
Recruitment Status : Withdrawn (PI decided to withdraw study)
First Posted : August 4, 2011
Last Update Posted : June 18, 2012
Information provided by:
University of Nebraska

Brief Summary:
The purpose of this study is to evaluate the clinical practice of the prophylactic use of ethanol locks for the prevention of catheter related blood stream infections in pediatric intestinal rehabilitation program patients requiring total parenteral nutrition.

Condition or disease Intervention/treatment
Blood Stream Infections Short Bowel Syndrome Drug: Ethanol Lock

Detailed Description:

Catheter- related blood stream infections are a serious complication for pediatric patients receiving parenteral nutrition. The leading causes of death in infants with short bowel syndrome (SBS) who are being treated with parenteral nutrition are central line sepsis and liver failure associated with the prolonged use of parenteral nutrition. (Cuffari, 2006) Incidence of infection ranges from 3% to 60% over the life span of each catheter. (Fratino, 2002) Interruption of nutritional support, antibiotic resistance and septic complications resulting from frequent infections can be life threatening to this fragile patient population. This patient population is dependent upon maintenance of central venous access for survival. Frequent hospitalizations, loss of work, and financial complications result in decreased quality of life for these patients and their caretakers. The cost of hospital treatment of catheter related bloodstream infections (CRBSI) has been estimated to range from $4000 to $56,000 for each occurrence. (MMWR 2002)

Vascular access sites are also limited in the pediatric population, and removal of central access for infection may diminish future ability to provide vital parenteral nutrition.(MMWR, 2002) Therefore, improvements in the ability to prevent infection are of utmost importance in this patient population.

The concept of antibiotic lock technique was developed in the late 1980s and was derived from various heparin lock protocols. Antibiotic locks have been used for both management and prevention of infection in vascular access devices. Antimicrobial choices for use in the antibiotic lock technique are dependent on the different pathogens suspected to infect the catheter lumen, characteristics of the organisms, and the pharmacodynamic properties of the antimicrobial agent. There is a risk of selection for multi-drug resistant organisms when antibiotic locks are utilized. In addition, heparin must be added to an antibiotic lock solution to maintain catheter patency.

More recently, ethanol locks have been utilized as a treatment option for children with CRBSIs. Ethanol is not only bactericidal and fungicidal in nature but also reveals thrombolytic properties. (Mouw, 2008) The thrombolytic properties eliminate the need for heparin addition to maintain catheter patency. Although utilized as treatment, ethanol is not currently being used for CRBSI prevention at our institution. Along with decreasing the risk of emerging antibiotic resistance, the investigators are attempting to determine if using ethanol as a lock solution will diminish the number of infections in the Intestinal Rehabilitation Program population, leading to decreased patient complications and costs. UNMC has the largest population of Intestinal Rehabilitation Program participants in the country making this a uniquely well-suited clinic in which to gather data surrounding this emerging infection-prevention strategy.

Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Official Title: Evaluation of the Clinical Practice of Using of a 70 % Ethanol Lock Solution for the Prevention of Catheter Related Blood Stream Infections in Pediatric Patients Undergoing Intestinal Rehabilitation
Study Start Date : December 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Group/Cohort Intervention/treatment
Intestinal Rehab Drug: Ethanol Lock
Ethanol Lock

Primary Outcome Measures :
  1. To determine the 90 day infection rate in eligible subjects for the term immediately prior to enrollment in the study protocol. [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. 90 day CRBSI rate in enrolled subjects. [ Time Frame: 90 days ]
  2. Type of organism involved in CRBSI, and the treatment strategy used for each infection. [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Short Bowel Syndrome

Inclusion Criteria:

  • Signed informed consent/assent and willingness to adhere to protocol
  • Intestinal rehabilitation patients with documented short bowel syndrome
  • Age: newborn to 19 years of age
  • Indwelling tunneled venous catheter placed for the purpose of total parenteral nutrition/IV fluids, with a 2 hour or longer window out of 24 hours for ethanol lock instillation
  • No history of alcohol abuse
  • No history of hypersensitivity to ethanol
  • No history or documented active seizure disorder

Exclusion Criteria:

  • Parent/guardian unwilling to sign consent
  • Active bacterial infection
  • Non-tunneled, non-permanent catheter (triple lumen or PICC)
  • Pre-existing condition that would prevent enrollment as determined by each patients' physician
  • Inability to adhere to protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01409772

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Kari A Simonsen, MD UNMC

Responsible Party: Kari Simonsen, MD, University of Nebraska Medical Center Identifier: NCT01409772     History of Changes
Other Study ID Numbers: 156-09-FB
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Communicable Diseases
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs