Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of Tetrasodium EDTA Catheter Lock Solution for Patients on Home Parenteral Nutrition:Ease of Use and Cost Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067245
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Johane Allard, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Catheter Complications Device: Tetrasodium EDTA catheter lock solution Not Applicable

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 in malabsorptive conditions and dysmotility). The intravenous provision of nutrition requires central venous access where a hyperosmolar nutrient solution can be infused. A variety of central venous catheters (CVCs) can be used, including peripherally inserted central catheters (PICC), tunneled catheters and implanted ports. The most common complication, and most frequent cause of hospitalization in patients on home PN is bloodstream infection.

There are several new devices or solutions that are being developed to be used as primary prophylaxis for CRBSI. These include catheters with antibacterial and/or anti-biofilm properties and different catheter lock solutions. Antibiotic lock solutions have been used for salvage of central venous catheters in confirmed CRBSI. However, it is not recommended as a primary prophylaxis due to the creation of resistant organisms. According to the United States Center for Disease Control (CDC), antibiotics 'should be used only to manage infection.' However, one antimicrobial solution, taurolidine, has not been found to promote the emergence of resistant bacterial strains and it has been used successfully as a lock solution to prevent CRBSI. Although an antibiotic may have anti-biofilm properties in high concentrations but it does not have anticoagulant properties. Ethanol lock solutions (varying concentrations, but usually 70%) have also been used successfully to reduce CRBSI, however, there have been adverse events when they are used in polyurethane lines and it does not inherently have anticoagulant properties. Historically, citrate lock solution has also been used to maintain catheter patency, but in a meta-analysis, there was no difference between heparin and citrate lock with regards to catheter thrombosis or catheter related bloodstream infection.

Although its use has been evaluated in hemodialysis catheters, there are no known studies examining the use of a tetra-sodium EDTA catheter lock solution in central venous catheters of patients on home PN. Although both hemodialysis and home PN require central venous catheters, there are many differences inherent to the different usages. First, the types of catheters that are used can differ. There is more variety in the types of catheters used for home PN. Second, most patients undergo hemodialysis on a fixed schedule, three times per week for 4 to 8 hours each time, and, for the majority of patients, this is done in-center, with the assistance of a nurse. On the other hand, home PN is usually administered five or more days per week, at home, over 12 or more hours. It can be either administered with the assistance of a home care nurse or by the patient and/or their family/partner. Furthermore, the substance infused through the catheter is different. Specifically, amino acids and fat emulsions are usually only infused in home PN, although electrolytes and fluids can be infused in both.

Kitelock™, 4% tetrasodium EDTA catheter lock solution is the sole product of SterileCare Inc, a private medical devices and equipment company registered federally in Canada, and based in Markham, Ontario. Kitelock™ is licensed as a medical device, class 2 (license #96962, issue date 2016-05-10), by Health Canada.

The aim of this study is to perform cost- and ease-of-use analyses in patients on home parenteral nutrition.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Use of Tetrasodium EDTA Catheter Lock Solution for Patients on Home Parenteral Nutrition: Ease of Use and Cost Analysis
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
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.
Device: 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 Measures :
  1. Ease of use [ Time Frame: 24 months ]
    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?


Secondary Outcome Measures :
  1. Time taken to use the catheter lock [ Time Frame: 24 months ]
    To evaluate time required to use the catheter lock solution by recording time taken to connect and disconnect TPN on the first and last Monday of every month.

  2. Cost analysis [ Time Frame: 24 months ]
    Cost analysis of using tetrasodium EDTA catheter lock solution versus heparin saline catheter lock solution



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067245


Contacts
Layout table for location contacts
Contact: Johane Allard 4163405159 dr.johane.allard@uhn.ca
Contact: Katherine Schwenger 4163404413 kschweng@uhnresearch.ca

Locations
Layout table for location information
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Johane Allard, MD, FRCPC    (416) 340-5159    johane.allard@uhn.ca   
Contact: Katherine Schwenger, PHD    (416)340-5159 ext 4413    kschweng@uhnresearch.ca   
Sub-Investigator: Ennaliza Salazar, MBCHB         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Layout table for investigator information
Study Chair: Ennaliza Salazar TPN team
  Study Documents (Full-Text)

Documents provided by Johane Allard, University Health Network, Toronto:
Study Protocol  [PDF] March 12, 2019


Publications:

Layout table for additonal information
Responsible Party: Johane Allard, Senior Researcher at University of Toronto, Gastroenterologist at University Health Network, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04067245     History of Changes
Other Study ID Numbers: 18-6325.0
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johane Allard, University Health Network, Toronto:
Home Total Parenteral Nutrition
Tetrasodium EDTA catheter lock solution
Catheter Complications
Catheter-Related Thrombosis
Catheter-Related Infections
Additional relevant MeSH terms:
Layout table for MeSH terms
Edetic Acid
Pharmaceutical Solutions
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action