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Use of Tetrasodium EDTA Catheter Lock Solution for Patients on HTPN

Catheter Complications

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 ongoing nutrition. However, the presence of a CVC is associated with a risk of thrombosis and bloodstream infection. Many different types of catheter lock solutions have been used to mitigate these risks. They include solutions primarily aimed at reducing thrombosis, such as heparin and citrate, and others primarily aimed at reducing infection such as ethanol and antibiotics (for example, taurolidine). One recently developed solution, tetrasodium EDTA, aims to reduce both thrombosis and infection. This scientific review provides an overview of central venous catheter lock solutions, and an ease-of-use and cost analysis comparing heparin and tetrasodium EDTA in one home parenteral nutrition program in Toronto, Canada.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

* Adult over the age of 18
* Both males and females
* Clinically stable for at least 4 weeks with no acute medical co-morbidities

Exclusion Criteria:

* 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

Study Location

Toronto General Hospital
Toronto General Hospital
Toronto, Ontario
Canada

Contact Study Team

Backup Contact

Katherine Schwenger, PHD

[email protected]
(416)340-5159
Primary Contact

Johane Allard, MD, FRCPC

[email protected]
(416) 340-5159
Study Sponsored By
University Health Network, Toronto
Participants Required
More Information
Study ID: NCT04067245