NCT05879835 · SterileCare Inc.
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
What this study is about
A multi-site, randomly assigned, 2-treatment group$1 where both patients and doctors know the treatment given trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (the usual treatment) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN).
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Boston, Massachusetts
- Omaha, Nebraska
- New York, New York
- Durham, North Carolina
- Cincinnati, Ohio
- Columbus, Ohio
- Fort Worth, Texas
- Seattle, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations