Recruiting

Tetrasodium EDTA

Sponsor:

University Health Network, Toronto

Code:

NCT04067245

Conditions

Catheter Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tetrasodium EDTA catheter lock solution

Study Details

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 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.

Conditions

Catheter Complications

Study ID

NCT04067245

Start date

Apr 1, 2019

Status verified date

Nov, 2022

Completion date

Mar 1, 2025

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Tetrasodium EDTA cathether lock solution

There is only one arm in this study where home parenteral nutrition patients who meet the inclusion criteria will receive tetrasodium EDTA catheter lock solution.

Interventions

Tetrasodium EDTA catheter lock solution

Home parenteral nutrition patients who meets inclusion criteria is to receive tetrasodium edta catheter lock solution. Patient will receive standard catheter lock solution of heparin/saline for 1 month, followed by tetrasodium EDTA catheter lock solution using withdrawal method for 1 month and followed by tetrasodium EDTA catheter lock solution using flush method for 1 month. In total, patient will stay in the study for 3 months. A phone call will be conducted before the start of the study to give instruction to patient regarding the use of catheter lock solution. Time taken to connect and disconnect TPN will be recorded by patients, twice a month on first and last mondays of the month for 3 months. A survey regarding the ease of use of catheter lock solution will be conducted at the end of each month via phone by nurse coodinator.

Primary outcome measure

  • Ease of use [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Johane Allard

4163405159dr.johane.allard@uhn.ca

Katherine Schwenger

4163404413kschweng@uhnresearch.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Johane Allard, MD, FRCPC

(416) 340-5159johane.allard@uhn.ca

Katherine Schwenger, PHD

(416)340-5159kschweng@uhnresearch.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 4, 2022

Last verified

Nov, 2022

Keywords

  • Home Total Parenteral Nutrition
  • Tetrasodium EDTA catheter lock solution
  • Catheter Complications
  • Catheter-Related Thrombosis
  • Catheter-Related Infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2022-11-04.