Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Paused · Not applicable
Conditions studied: Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
In brief
In this research study we want to learn more about a study drug, tetrasodium sodium EDTA (Kitelock™) for maintaining the patency (blood flow) through a central venous catheter. Catheter occlusions such as blood clots have been shown to increase the risk of central line-associated bloodstream infection (CLABSI). This treatment consists of instilling a daily a dose of a solution , similar to heparin or saline lock flushes, into the catheter when it is not in use. The aim is to prevent CLABSI without increasing complications such as catheter breakage.
Key facts
- Study ID
- NCT04559334
- Run by
- Boston Children's Hospital
- People needed
- 15
- Starts
- 2020-12-21
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-04-15
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Presence of a tunneled central venous catheter or peripherally inserted central catheter (PICC) for administration of PN or intravenous hydration fluids to treat intestinal failure
- Patients aged 3 months to 18 years old inclusive
- Minimum patient weight of at least 5 kilograms
- History of at least one thrombolytic occlusion and/or CLABSI event
- Signed patient informed consent
- Clinically stable for at least 4 weeks with no acute medical co-morbidities
You may not qualify if…
- Pregnancy or nursing mother
- Enrollment in any other clinical trial involving an investigational agent (unless approved by the principal investigators of the other trial)
- The parent or guardian or child unwilling to provide consent or assent
- Clinical instability such as the following:
- Acute pulmonary edema
- Acute myocardial infarction
- Acute stroke
- Acute thromboembolism
- Metabolic acidosis
- Sepsis
- Coagulopathy with prolonged activated partial thromboplastin time (aPTT) or international normalized ratio (INR)
- Severe hypoglycemia
- Subjects who are hypersensitive or allergic to EDTA
- Active therapy with long-term anti-microbial agents, such as taurolidine (not including patients receiving intermittent antimicrobial treatment for small intestinal bacterial overgrowth)
- A compromised catheter defined as one which has been repaired several times.
Where it is running
- Childrens's Hospital Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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