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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Pediatric Intestinal Failure
• Intervention / Treatment: Device: KiteLock 4% Sterile Catheter Lock Solution; Device: Heparin Lock Solution

Detailed Description

A total of 124 (62 per arm) will be enrolled into the study. Screening and informed consent (and assent if applicable) will be obtained prior to study procedures. The baseline assessment will be completed at recruitment to the study. Once the baseline assessment is complete and eligible subjects are randomized, the study drug will be dispensed per protocol. The study follow-up period will be 52 weeks. Four follow-up clinical in-person visits will occur at 2,12, 28, 40 and 52 weeks. Visits will be conducted by physicians or nurse practitioners. The study visits will assess general status, study bloodwork, adverse events, catheter patency, alteplase use, infection assessment, catheter integrity, and provide investigational product. Telephone follow up will occur on day-3 of intervention, and once per 4 weeks, as well as in the event of outpatient care/hospital admission, or safety event. Subject daily diaries will be utilized for detailed monitoring. Diary recordings will include adverse events, including occlusive events, and any subject specific details (e.g. dwell times, heparin flushing vs. aspiration) or issues in the delivery of the study locking solutions.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanne Greco; Phone Number: 6472006232; Email: jgreco@sterilecareinc.com

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Jaeson Kim; Phone Number: 617-355-5045; Email: Jaeson.Kim@childrens.harvard.edu
      • Contact: Zainab Hussein; Phone Number: 617-355-6439; Email: Zainab.Hussein@childrens.harvard.edu
      • Principal Investigator: Alexandra Carey, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Not yet recruiting
      • University of Nebraska Medical Center
      • Principal Investigator: David Mercer, MD
      • Contact: Jill Povondra; Phone Number: 402.559.2556; Email: jill.povondra@unmc.edu
      • Contact: Michelle Leahy; Phone Number: 402.559.0488; Email: michelle.leahy@unmc.edu
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Nyph/Cumc
      • Contact: Candido Batres, MD, CCRC; Phone Number: 212-305-6274; Email: cb2269@cumc.columbia.edu
      • Principal Investigator: Sivan Kinberg, MD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Principal Investigator: Debra Sudan, MD
      • Contact: Kennesha M Bragg, MS; Phone Number: 919.681.8062; Email: kennesha.myrick.bragg@duke.edu
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Principal Investigator: Paul Wales, MD
      • Contact: Crystal Slaughter, BA, CCCR; Phone Number: 513.636-0137; Email: crystal.slaughter@cchmc.org
      • Contact: Kim Klotz, MSN, RN, CNRI; Phone Number: (513) 636-4415; Email: kimberly.klotz@cchmc.org
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Kaitlyn Brown, RN, BSN; Phone Number: 614-722-2286; Email: Kaitlyn.Brown2@nationwidechildrens.org
      • Principal Investigator: Ethan Mezoff, MD
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Cook Children's Health Care System
      • Contact: Alexis Gossett; Email: Alexis.gossett@cookchildrens.org
      • Contact: Brittany Simpson; Phone Number: 682.303.1978; Email: Brittany.simpson@cookchildrens.org
      • Principal Investigator: Bankole Osuntokun, MD
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Contact: Melissa Young; Phone Number: 206-987-1037; Email: melissa.young@seattlechildrens.org
      • Contact: Teresa Chen; Phone Number: 206-987-6649; Email: teresa.chen@seattlechildrens.org
      • Principal Investigator: Danielle Wendel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 trial and willing to comply with randomization and study protocol.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KiteLock 4% Sterile Catheter Lock Solution; 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; 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.
Active Comparator: Heparin Lock Solution; 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; Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Central Line-Associated Blood Stream Infections (CLABSI)	CLABSI is defined per the Centers for Disease Control-National Healthcare Safety Network (CDC-NSHN) definition. CLABSI rates will be pooled for each study arm and reported per 1000 catheter days.	52 weeks
Incidence of breakage, removal, or reinsertion of catheter	Breakage of the catheter line, surgical removal of the line or reinsertion of the line into the vein will be recorded. Event rates will be pooled for each study arm and reported per 1000 catheter days.	52 weeks
Incidence of central venous thrombosis	Central venous thrombosis shall be clinically diagnosed by investigators, including the collection of brain imaging. Central Venous Thrombosis rates will be pooled for each study arm and reported per 1000 catheter days.	52 weeks
Proportion of subjects with development of Intestinal failure-associated liver disease (IFALD)	IFALD is defined as (cholestasis defined as conjugated bilirubin >2mg/dL, advanced IFALD defined as conjugated bilirubin >6mg/dL) sustained for >2 weeks in absence of sepsis. Proportion shall be reported for each study arm	52 weeks
Incidence of lock-related Serious Adverse Events (SAEs)	SAEs are defined per Good Clinical Practice. SAE rates will be pooled for each study arm and reported per 1000 catheter days.	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects requiring hospital admission related to catheter complications	Proportion shall be reported for each study arm.	52 weeks
Length of stay for hospitalization related to catheter complications	Length of hospital stay shall be reported in days. Mean shall be reported for each study arm	52 weeks

Collaborators and Investigators

• Sponsor: SterileCare Inc.
• Collaborators: Dicentra Inc.; Meditrial SrL
• Investigators: Principal Investigator: Paul Wales, MD, Cincinnati Children's

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: heparin; catheter lock solution; central venous catheter; parenteral nutrition; intestinal failure; total parenteral nutrition; pediatric intestinal failure; KiteLock 4%
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Intestinal Failure; Hyperphagia; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Pharmaceutical Solutions; Heparin
• Other Study ID Numbers: CT23-001-SC001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No