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

Inclusion Criteria:

1. Patients managed by the intestinal rehabilitation program at one of theparticipating centers.

2. Diagnosis of intestinal failure defined as need for PN support for >60 days inprevious 74 days for primary intestinal disease (short bowel syndrome, primarymotility 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 40weeks 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, orperipherally 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 andwilling 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 priorto 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.