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
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|ClinicalTrials.gov Identifier: NCT01409772|
Recruitment Status : Withdrawn (PI decided to withdraw study)
First Posted : August 4, 2011
Last Update Posted : June 18, 2012
|Condition or disease||Intervention/treatment|
|Blood Stream Infections Short Bowel Syndrome||Drug: Ethanol Lock|
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|
|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|
Drug: Ethanol Lock
- 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 ]
- 90 day CRBSI rate in enrolled subjects. [ Time Frame: 90 days ]
- Type of organism involved in CRBSI, and the treatment strategy used for each infection. [ Time Frame: 90 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT01409772
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Kari A Simonsen, MD||UNMC|