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Tetrasodium EDTA for Catheter Complications
N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Inability to give informed consent
Clinical instability such as 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial found that tetrasodium EDTA was more effective than heparin at reducing thrombosis and infection in patients receiving parenteral nutrition through a central venous catheter.
Who is the study for?
This trial is for adults over 18 who are stable on home total parenteral nutrition (HTPN) without acute illnesses. It's not for those allergic to tetrasodium EDTA, unable to consent, with substance abuse issues, pregnant or breastfeeding women, or those with certain severe medical conditions.
What is being tested?
The study tests a catheter lock solution called Tetrasodium EDTA in patients using HTPN. The goal is to see if it reduces complications like blood clots and infections better than other solutions such as heparin.
What are the potential side effects?
Potential side effects may include reactions at the catheter site due to sensitivity to Tetrasodium EDTA ingredients. However, specific side effects aren't listed; they will be monitored throughout the trial.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand and agree to the study's details.
Select...
I do not have any severe, uncontrolled health conditions currently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ease of use
Secondary study objectives
Cost analysis
Time taken to use the catheter lock
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tetrasodium EDTA cathether lock solutionExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
503,152 Total Patients Enrolled
Ennaliza SalazarStudy ChairTPN team
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My health has been stable for the last 4 weeks without any new serious illnesses.I am on a long-term anti-microbial treatment, not for small intestinal issues.I am either male or female.You have a history of alcohol or drug abuse.I am unable to understand and agree to the study's details.You are currently taking part in another clinical trial involving home TPN that could affect the accuracy of the results.I am over 18 years old.You are allergic or extremely sensitive to the ingredients in tetrasodium EDTA.I do not have any severe, uncontrolled health conditions currently.
Research Study Groups:
This trial has the following groups:- Group 1: Tetrasodium EDTA cathether lock solution
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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