RECRUITING

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

Conditions

Pediatric Intestinal Failure catheter lock solution intestinal failure central venous catheter KiteLock 4%heparin total parenteral nutrition parenteral nutrition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Safety and Effectiveness of 4% Tetrasodium Ethylenediaminetetraacetic Acid Catheter Lock Solution in Preventing Central Venous Catheter Occlusions in Children with Intestinal Failure: a Randomized Controlled Trial

Quick Facts

Study Start:2024-06-21

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05879835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Weeks to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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 trial and willing to comply with randomization and study protocol.	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 prior to 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.

Inclusion Criteria

Exclusion 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 trial and willing to comply with randomization and study protocol.

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 prior to 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.

Contacts and Locations

Study Contact

Joanne Greco

CONTACT

6472006232

jgreco@sterilecareinc.com

Principal Investigator

Paul Wales, MD

PRINCIPAL_INVESTIGATOR

Cincinnati Children's

Study Locations (Sites)

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Cook Children's Health Care System

Fort Worth, Texas, 76104

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: SterileCare Inc.

Paul Wales, MD, PRINCIPAL_INVESTIGATOR, Cincinnati Children's

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-21

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-06-21

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

catheter lock solution
pediatric intestinal failure
intestinal failure
central venous catheter
KiteLock 4%
heparin
total parenteral nutrition
parenteral nutrition

Additional Relevant MeSH Terms

Pediatric Intestinal Failure