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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 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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

Tetrasodium EDTA cathether lock solution Clinical Trial Eligibility Overview. Trial Name: NCT04067245 — N/A
Catheter Complications Research Study Groups: Tetrasodium EDTA cathether lock solution
Catheter Complications Clinical Trial 2023: Tetrasodium EDTA cathether lock solution Highlights & Side Effects. Trial Name: NCT04067245 — N/A
Tetrasodium EDTA cathether lock solution 2023 Treatment Timeline for Medical Study. Trial Name: NCT04067245 — N/A
~0 spots leftby Dec 2024