Pediatric Intestinal FailureNCT05879835
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
A study testing KiteLock 4% Sterile Catheter Lock Solution and Heparin Lock Solution in people with Pediatric Intestinal Failure, run by SterileCare Inc. at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 weeks to 18 years
- Conditions the study is for
- Pediatric Intestinal Failure
- What is being tested?
- KiteLock 4% Sterile Catheter Lock Solution and Heparin Lock Solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 8 sitesUnited States
- Study dates
- 21 Jun 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- Diagnosis of immunodeficiency disorder.
- Unstable medical condition requiring hospital admission
- Received antibiotic therapy for CLABSI within last 14 days.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Jaeson Kim, 617-355-5045, Jaeson.Kim@childrens.harvard.edu
Zainab Hussein, 617-355-6439, Zainab.Hussein@childrens.harvard.edu
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Crystal Slaughter, BA, CCCR, 513.636-0137, crystal.slaughter@cchmc.org
Kim Klotz, MSN, RN, CNRI, (513) 636-4415, kimberly.klotz@cchmc.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Kaitlyn Brown, RN, BSN, 614-722-2286, Kaitlyn.Brown2@nationwidechildrens.org
Ethan Mezoff, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Kennesha M Bragg, MS, 919.681.8062, kennesha.myrick.bragg@duke.edu
Debra Sudan, MD
- Recruiting
Cook Children's Health Care System
Fort Worth, Texas, 76104
Brittany Simpson, 682.303.1978, Brittany.simpson@cookchildrens.org
Alexis Gossett, Alexis.gossett@cookchildrens.org
- Recruiting
Nyph/Cumc
New York, New York, 10032
Candido Batres, MD, CCRC, 212-305-6274, cb2269@cumc.columbia.edu
Sivan Kinberg, MD
- Not yet recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Jill Povondra, 402.559.2556, jill.povondra@unmc.edu
Michelle Leahy, 402.559.0488, michelle.leahy@unmc.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Teresa Chen, 206-987-6649, teresa.chen@seattlechildrens.org
Melissa Young, 206-987-1037, melissa.young@seattlechildrens.org
About this study
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
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).
Read the 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.
- Conditions
- Pediatric Intestinal Failure
- Being tested
- KiteLock 4% Sterile Catheter Lock Solution, Heparin Lock Solution
- Keywords
- catheter lock solution, pediatric intestinal failure, intestinal failure, central venous catheter, KiteLock 4%, heparin, total parenteral nutrition, parenteral nutrition
- Medical subject headings
- Intestinal Failure, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KiteLock 4% Sterile Catheter Lock SolutionDevice
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.
Heparin Lock SolutionDevice
Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Heparin Lock Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start21 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Intestinal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multisite, randomized, open-label, 2-arm parallel-group superiority trial
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SterileCare Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc., Meditrial SrL
- Responsible party
- Sponsor
- Investigators
- Paul Wales, MD, Principal investigator, Cincinnati Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879835
- Sponsor's protocol ID
- CT23-001-SC001
- Status last verified
- Jun 2026
- First submitted
- 9 May 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 32770561
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05879835
- Acronym / sponsor ID
- CT23-001-SC001
- Conditions
- Pediatric Intestinal Failure
- Keywords
- catheter lock solution, pediatric intestinal failure, intestinal failure, central venous catheter, KiteLock 4%, heparin, total parenteral nutrition, parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- SterileCare Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc., Meditrial SrL
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multisite, randomized, open-label, 2-arm parallel-group superiority trial
| Arm | Type | Receives |
|---|---|---|
| KiteLock 4% Sterile Catheter Lock Solution | Experimental | Device: KiteLock 4% Sterile Catheter Lock Solution4% 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. |
| Heparin Lock Solution | Active comparator | Device: Heparin Lock SolutionHeparin lock solution will be administered daily per investigator judgement, given its significant clinical risk in the youngest/smallest/vulnerable subjects. |
Who may qualify
- Ages
- 4 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KiteLock 4% Sterile Catheter Lock SolutionKiteLock™ 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. | Device | KiteLock 4% Sterile Catheter Lock Solution |
| Heparin Lock SolutionNonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection. | Device | Heparin Lock Solution |
Primary outcome
Incidence of catheter occlusions
Time frame: 52 weeks
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.
5 secondary outcomes
Incidence of Central Line-Associated Blood Stream Infections (CLABSI)
Time frame: 52 weeks
Incidence of breakage, removal, or reinsertion of catheter
Time frame: 52 weeks
Incidence of central venous thrombosis
Time frame: 52 weeks
Proportion of subjects with development of Intestinal failure-associated liver disease (IFALD)
Time frame: 52 weeks
Incidence of lock-related Serious Adverse Events (SAEs)
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 32770561Quirt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Wales, MD principal investigator
Cincinnati Children's
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KiteLock 4% Sterile Catheter Lock Solution and Heparin Lock Solution in people with Pediatric Intestinal Failure, run by SterileCare Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanne Greco (6472006232, jgreco@sterilecareinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter occlusions (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05879835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.