KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure

Inclusion Criteria

• Patients managed by the intestinal rehabilitation program at one of the participating centers.
• 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).
• Expectation of the treating physician that the patient will require PN for at least 6 months following enrollment.
• Age less than 18 years at diagnosis but greater than 4 weeks chronological age or 40 weeks estimated gestational age, whichever is greater.
• Stable TPN cycling (4 hours off TPN minimum per day) enabling home TPN management
• Presence of a tunneled central venous catheter (CVC), port-a-catheter, or peripherally inserted central catheter (PICC).
• Clinical stability for at least 4 weeks and no acute medical comorbidities.
• A minimum dwell time of 4 consecutive hours daily.
• Care provider willing to provide informed consent to participate in the trial and willing to comply with randomization and study protocol.

Exclusion Criteria

• A temporary CVC (jugular or femoral) or peripheral catheter.
• 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).
• Known hypersensitivity, allergy, or reaction to EDTA.
• Pregnancy or nursing mother.
• Participation in another investigational device or drug trial within 30 days prior to enrollment (unless approved by the principal investigators of the trial).
• Severe coagulopathy (platelets \<50,000, or INR > 1.5).
• Diagnosis of immunodeficiency disorder.
• Unstable medical condition requiring hospital admission
• Received antibiotic therapy for CLABSI within last 14 days.