KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure (NCT05879835) | Clinical Trial Compass
RecruitingNot Applicable
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
United States124 participantsStarted 2024-06-21
Plain-language 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).
Who can participate
Age range4 Weeks – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
✕. 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