Clinical trial

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

Name

0156-09-FB

Description

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.

Trial arms

Trial start

2009-05-01

Estimated PCD

2009-07-09

Trial end

2009-07-09

Status

Withdrawn

Treatment

Ethanol Lock

Arms:

Intestinal Rehab

Other names:

70% ethanol

Primary endpoint

90 day infection rate prior to enrollment

90 days

Eligibility 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

Protocol

{'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2023-08-22

1 organization

1 product

2 indications

Organization

University of Nebraska

Product

Ethanol

Indication

Bloodstream Infections

Indication

Short Bowel Syndrome