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

NCT05879835 | Recruiting DMC FDA Device

• 1 other identifier: CT23-001-SC001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 8

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).

Conditions

Pediatric Intestinal Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of catheter occlusions

  Occlusion is defined as requiring chemical or surgical intervention to restore patency. Occlusion rates will be pooled for each study arm and reported per 1000 catheter days.

  52 weeks

Secondary Outcomes (5)

• Incidence of Central Line-Associated Blood Stream Infections (CLABSI)

  52 weeks

• Incidence of breakage, removal, or reinsertion of catheter

  52 weeks

• Incidence of central venous thrombosis

  52 weeks

• Proportion of subjects with development of Intestinal failure-associated liver disease (IFALD)

  52 weeks

• Incidence of lock-related Serious Adverse Events (SAEs)

  52 weeks

Other Outcomes (2)

• Proportion of subjects requiring hospital admission related to catheter complications

  52 weeks

• Length of stay for hospitalization related to catheter complications

  52 weeks

Study Arms (2)

KiteLock 4% Sterile Catheter Lock Solution

EXPERIMENTAL

4% Tetrasodium EDTA lock solution (KiteLock 4% Sterile Catheter Lock Solution; SterileCare Inc., Canada) will be administered 4-24 hours daily while the patient is cycled off their PN, as per site standard operating procedures.

Device: KiteLock 4% Sterile Catheter Lock Solution

Heparin Lock Solution

ACTIVE COMPARATOR

Heparin lock solution will be administered daily per investigator judgement, given its significant clinical risk in the youngest/smallest/vulnerable subjects.

Device: Heparin Lock Solution

Interventions

KiteLock 4% Sterile Catheter Lock Solution DEVICE

KiteLock™ is a clear, colorless, and sterile 4% (40 mg/ml) tetrasodium EDTA solution that contains no preservatives, latex, antibiotics, or ethanol and is nonpyrogenic. Tetrasodium salt of EDTA has been shown to disrupt in vivo and ex vivo-generated biofilms by destabilizing the structural integrity of micro-organisms at the cellular level.

KiteLock 4% Sterile Catheter Lock Solution

Heparin Lock Solution DEVICE

Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.

Heparin Lock Solution

Eligibility Criteria

• Age: 4 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SterileCare Inc.: lead
• Dicentra Inc.: collaborator
• Meditrial SrL: collaborator

Study Sites (8)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

NOT YET RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Cook Children's Health Care System

Fort Worth, Texas, 76104, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (1)

• Quirt J, Belza C, Pai N, Clause RF, Markovic F, Wong-Sterling S, Avitzur Y, Wales PW. Reduction of Central Line-Associated Bloodstream Infections and Line Occlusions in Pediatric Intestinal Failure Patients Receiving Long-Term Parenteral Nutrition Using an Alternative Locking Solution, 4% Tetrasodium Ethylenediaminetetraacetic Acid. JPEN J Parenter Enteral Nutr. 2021 Aug;45(6):1286-1292. doi: 10.1002/jpen.1989. Epub 2020 Aug 30.

  PMID: 32770561 BACKGROUND

MeSH Terms

Conditions

Intestinal Failure; Hyperphagia

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Wales, MD

  Cincinnati Children's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Greco

CONTACT

6472006232; jgreco@sterilecareinc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multisite, randomized, open-label, 2-arm parallel-group superiority trial

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 30, 2023
• Study Start: June 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2024-11

Locations

US (8)