Using KiteLock 4% EDTA to prevent catheter blockages in children with intestinal failure

Safety and Effectiveness of 4% Tetrasodium Ethylenediaminetetraacetic Acid Catheter Lock Solution in Preventing Central Venous Catheter Occlusions in Children With Intestinal Failure: A Randomized Controlled Trial

This study is testing whether a new catheter lock solution can help prevent blockages in central venous catheters for children with intestinal failure who need total parenteral nutrition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 4 Weeks to 18 Years
• Sex: All
• Sponsor: SterileCare Inc. (Industry-sponsored)
• Locations: 8 sites (Boston, Massachusetts and 7 other locations)
• Trial ID: NCT05879835 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-site, randomized, open-label study comparing the effectiveness of a 4% Tetrasodium (EDTA) catheter lock solution against the standard heparin lock solution in preventing occlusions of central venous catheters in pediatric patients with intestinal failure who are on total parenteral nutrition (TPN). A total of 124 participants will be enrolled, with follow-up assessments occurring over a 52-week period. The study will monitor various outcomes, including catheter patency, adverse events, and overall health status through in-person visits and daily diaries. The goal is to determine if the KiteLock solution can improve catheter function and reduce complications associated with TPN.

Who should consider this trial

Good fit: Ideal candidates are children under 18 years with a diagnosis of intestinal failure requiring long-term parenteral nutrition and stable catheter management.

Not a fit: Patients with acute medical comorbidities or those not requiring long-term TPN may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved catheter management and reduced complications for children with intestinal failure on TPN.

How similar studies have performed: While the use of catheter lock solutions is common, this specific approach with KiteLock 4% EDTA is novel and has not been extensively tested in this population.

Eligibility criteria

Inclusion Criteria:

1. Patients managed by the intestinal rehabilitation program at one of the participating centers.
2. Diagnosis of intestinal failure defined as need for PN support for \>60 days in previous 74 days for primary intestinal disease (short bowel syndrome, primary motility disorder, mucosal enteropathy).
3. Expectation of the treating physician that the patient will require PN for at least 6 months following enrollment.
4. Age less than 18 years at diagnosis but greater than 4 weeks chronological age or 40 weeks estimated gestational age, whichever is greater.
5. Stable TPN cycling (4 hours off TPN minimum per day) enabling home TPN management
6. Presence of a tunneled central venous catheter (CVC), port-a-catheter, or peripherally inserted central catheter (PICC).
7. Clinical stability for at least 4 weeks and no acute medical comorbidities.
8. A minimum dwell time of 4 consecutive hours daily.
9. Care provider willing to provide informed consent to participate in the trial and willing to comply with randomization and study protocol.

Exclusion Criteria:

1. A temporary CVC (jugular or femoral) or peripheral catheter.
2. Patients receiving long-term PN, but not due to a primary intestinal disorder (i.e., oncology patients or premature neonates on PN due to intestinal immaturity).
3. Known hypersensitivity, allergy, or reaction to EDTA.
4. Pregnancy or nursing mother.
5. Participation in another investigational device or drug trial within 30 days prior to enrollment (unless approved by the principal investigators of the trial).
6. Severe coagulopathy (platelets \<50,000, or INR \> 1.5).
7. Diagnosis of immunodeficiency disorder.
8. Unstable medical condition requiring hospital admission
9. Received antibiotic therapy for CLABSI within last 14 days.

Where this trial is running

Boston, Massachusetts and 7 other locations

• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (Not_yet_recruiting)
• Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
• Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
• Cook Children's Health Care System — Fort Worth, Texas, United States (Recruiting)
• Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Paul Wales, MD — Cincinnati Children's
• Study coordinator: Joanne Greco

Conditions Pediatric Intestinal Failure; catheter lock solution; pediatric intestinal failure; intestinal failure; central venous catheter; KiteLock 4%; heparin; total parenteral nutrition