Use of Tetrasodium EDTA Catheter Lock Solution for Patients on HTPN

NCT04067245 | Unknown

• 1 other identifier: 18-6325.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ease of use

  Acceptability of the new catheter lock solution by administering a questionnaire survey that will be conducted by the end of the usage. The questionnares will require the participant to rate the overall satisfaction of the product as '1. unsatisfied or 2. neutral or 3. satistified' and to rate the amount of time it takes to prepare the product as '1. took long or 2. neutral or 3. doesn't take too long and 3rd question compared to usual product (heparin), how easy is this product as '1. harder than heparin or 2. the same or 3. easier than heparin' and last question is ask if participant would continue to use this lock solution 'Yes' or 'No' and why not?

  24 months

Secondary Outcomes (2)

• Time taken to use the catheter lock

  24 months

• Cost analysis

  24 months

Study Arms (1)

Tetrasodium EDTA cathether lock solution

OTHER

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.

Device: Tetrasodium EDTA catheter lock solution

Interventions

Tetrasodium EDTA catheter lock solution DEVICE

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.

Tetrasodium EDTA cathether lock solution

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (6)

• Percival SL, Kite P, Eastwood K, Murga R, Carr J, Arduino MJ, Donlan RM. Tetrasodium EDTA as a novel central venous catheter lock solution against biofilm. Infect Control Hosp Epidemiol. 2005 Jun;26(6):515-9. doi: 10.1086/502577.

  PMID: 16018425 BACKGROUND

• Kanaa M, Wright MJ, Akbani H, Laboi P, Bhandari S, Sandoe JA. Cathasept Line Lock and Microbial Colonization of Tunneled Hemodialysis Catheters: A Multicenter Randomized Controlled Trial. Am J Kidney Dis. 2015 Dec;66(6):1015-23. doi: 10.1053/j.ajkd.2015.04.047. Epub 2015 Jun 30.

  PMID: 26141306 BACKGROUND

• Banfi G, Salvagno GL, Lippi G. The role of ethylenediamine tetraacetic acid (EDTA) as in vitro anticoagulant for diagnostic purposes. Clin Chem Lab Med. 2007;45(5):565-76. doi: 10.1515/CCLM.2007.110.

  PMID: 17484616 BACKGROUND

• Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.

  PMID: 19489710 BACKGROUND

• O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93. doi: 10.1093/cid/cir257. Epub 2011 Apr 1. No abstract available.

  PMID: 21460264 BACKGROUND

• Zhao Y, Li Z, Zhang L, Yang J, Yang Y, Tang Y, Fu P. Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2014 Mar;63(3):479-90. doi: 10.1053/j.ajkd.2013.08.016. Epub 2013 Oct 11.

  PMID: 24125729 BACKGROUND

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Ennaliza Salazar

  TPN team

  STUDY CHAIR

Central Study Contacts

Johane Allard

CONTACT

4163405159; dr.johane.allard@uhn.ca

Katherine Schwenger

CONTACT

4163404413; kschweng@uhnresearch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher at University of Toronto, Gastroenterologist at University Health Network

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: August 26, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)