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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Nyph/Cumc
  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

Study contacts

• Principal investigator: Paul Wales, MD — Cincinnati Children's
• Study coordinator: Joanne Greco
• Email: jgreco@sterilecareinc.com
• Phone: 6472006232

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding quality of life in children with intestinal failure

  This study looks at how living with intestinal failure affects the quality of life for children and what factors might make it better or worse for them and their families.

  Recruiting at 13 sites Boston Children's Hospital · Birmingham, Alabama and 13 other locations · NCT04629014

• Resting energy tests in people with normal digestion vs. intestinal failure

  This study tests resting energy expenditure in adults with and without intestinal failure to help tailor nutrition needs.

  Recruiting Institute of Oncology Ljubljana · Ljubljana · NCT07714499

• Anabolic response to IV amino acids in people with chronic intestinal failure

  This will test whether giving IV amino acids helps people with chronic intestinal failure on home parenteral nutrition build and maintain body protein and better match their individual protein needs.

  Recruiting Institute of Oncology Ljubljana · Ljubljana · NCT07422792

• AI-guided IV nutrition for newborns in the NICU

  This project will try an AI tool that suggests IV nutrition (TPN) for newborns in the NICU who cannot feed by mouth to see if it helps clinicians order the right formula more quickly and accurately.

  Recruiting Takeoff41, Inc. · Stanford, California · NCT07414576

• Observing pediatric patients who have stopped using parenteral nutrition

  This study looks at children who have stopped using parenteral nutrition to see what health issues they might face afterward and to find out which kids are most at risk.

  Recruiting The Hospital for Sick Children · Toronto, Ontario · NCT06525753

• Using ultrasound-based measures to check liver health in children

  This project will test whether ultrasound techniques like shear wave elastography, shear wave dispersion, and attenuation imaging can noninvasively characterize liver disease in children who have or may have liver problems.

  Recruiting Sahlgrenska University Hospital · Gothenburg, Västra Götaland County · NCT07202910

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.