Status:
UNKNOWN
Use of Tetrasodium EDTA Catheter Lock Solution for Patients on HTPN
Lead Sponsor:
University Health Network, Toronto
Conditions:
Catheter Complications
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Parenteral nutrition (PN) is a lifesaving therapy in patients with chronic intestinal failure. PN is administered via a central venous catheter (CVC), and patients are dependent on this line for ongoi...
Detailed Description
Parenteral nutrition (PN) is a life-sustaining therapy required in patients who do not have a functioning gastrointestinal tract. This can be either second to surgical removal, or malfunction (such as...
Eligibility Criteria
Inclusion
- Adult over the age of 18
- Both males and females
- Clinically stable for at least 4 weeks with no acute medical co-morbidities
Exclusion
- Inability to give informed consent
- Alcohol or drug abuse
- Pregnant and lactating women
- Clinical instability such as the following:
- Acute pulmonary edema
- Decompensated heart failure
- Decompensated chronic liver disease
- Severe post-traumatic conditions
- Uncontrolled diabetes mellitus
- Acute myocardial infarction
- Acute stroke
- Acute thromboembolism
- Metabolic acidosis
- Sepsis
- Hypotonic dehydration
- Coagulopathy with prolonged aPTT or INR
- Unstable oncology patient
- Subjects who are hypersensitive or allergic to the product ingredients of tetrasodium EDTA
- Active therapy with long-term anti-microbial, such as taurolidine (not including patients receiving intermitted antimicrobial treatment for small intestinal bacterial overgrowth)
- Active participation in another home TPN clinical trial which may interfere with the results
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04067245
Start Date
April 1 2019
End Date
March 1 2025
Last Update
November 4 2022
Active Locations (1)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4