KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN).
Conditions:
Pediatric Intestinal Failure
Study Start (Actual) 2024-06-21
Primary Completion (Estimated) 2025-12
Study Completion (Estimated) 2025-12
Enrollment (Estimated) 124
Study Type INTERVENTIONAL
Phase NA
Locations:
📍 Omaha, Nebraska, United States
📍 Cincinnati, Ohio, United States

Eligibility Criteria

Description

    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.
Ages Eligible for Study: 4 Weeks to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2023-05-09
  • First Submitted that Met QC Criteria2023-05-18
  • First Posted2023-05-30

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-06-21
  • Last Update Posted2024-06-25
  • Last Verified2024-06