KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
Trial Parameters
Brief Summary
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).
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 t