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

This study has been withdrawn prior to enrollment.
(PI decided to withdraw study)
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01409772
First received: May 22, 2009
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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 Intervention
Blood Stream Infections
Short Bowel Syndrome
Drug: Ethanol Lock

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 90 day CRBSI rate in enrolled subjects. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Type of organism involved in CRBSI, and the treatment strategy used for each infection. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intestinal Rehab Drug: Ethanol Lock
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.

  Eligibility

Ages Eligible for Study:   up to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Short Bowel Syndrome

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409772

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

No publications provided

Responsible Party: Kari Simonsen, MD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01409772     History of Changes
Other Study ID Numbers: 156-09-FB
Study First Received: May 22, 2009
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014