Status:
WITHDRAWN
Evaluation of 70% Ethanol Lock Solution to Prevent Catheter Related Blood Stream Infections in Pediatric Patients
Lead Sponsor:
University of Nebraska
Conditions:
Blood Stream Infections
Short Bowel Syndrome
Eligibility:
All Genders
Up to 25 years
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 rehabilit...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 9 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01409772
Start Date
May 1 2009
End Date
July 9 2009
Last Update
August 22 2023
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