Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients

NCT04559334 | Suspended FDA Device

• 1 other identifier: IRB-P00035952
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

In this research study we want to learn more about a study drug, tetrasodium sodium EDTA (Kitelock™) for maintaining the patency (blood flow) through a central venous catheter. Catheter occlusions such as blood clots have been shown to increase the risk of central line-associated bloodstream infection (CLABSI). This treatment consists of instilling a daily a dose of a solution , similar to heparin or saline lock flushes, into the catheter when it is not in use. The aim is to prevent CLABSI without increasing complications such as catheter breakage.

Conditions

Central Line Complication; Central Line-associated Bloodstream Infection (CLABSI)

Keywords

central venous catheter; CLABSI; catheter occlusion; vascular access device; catheter patency; intestinal failure; parenteral nutrition

Outcome Measures

Primary Outcomes (3)

• The Number of participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  The number of treatment-related events as assessed by CTCAE v4.0 will be tracked for all study participants receiving 4% T-EDTA lock solution

  through study completion, an average of 1 year

• The Number of Participants with Catheter Occlusions

  The number of participants with catheter occlusions based on thrombolytic usage or need for catheter removal as assessed during clinical visits and admissions to the hospital or emergency room.

  through study completion, an average of 1 year

• The Number of Participants with Catheter Breaks

  The number of catheter breaks requiring catheters to be repaired or replaced will be collected based on emergency room and hospital records.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• The Number of Central Line Associated Bloodstream Infections (CLABSIs)

  through study completion, an average of 1 year

Study Arms (1)

open label

OTHER

All participants will receive Tetrasodium EDTA Catheter Lock Solution (KiteLock™ 4% Sterile Catheter Lock Solution)

Device: Tetrasodium EDTA Catheter Lock Solution

Interventions

Tetrasodium EDTA Catheter Lock Solution DEVICE

KiteLock™ 4% Sterile Catheter Lock Solution is a single use, clear, colorless and sterile solution. It is free of preservatives, alcohol and latex and is non-pyrogenic. KiteLock™ 4% is an aqueous solution containing a mixture of edetate tetrasodium and edetate trisodium. The solution composition is equivalent to 28 mg/mL edetate. EDTA is a known chelator. This means it has an affinity for metals and elements such as calcium. As a primary mechanism of action, it acts as a space occupying solution to prevent blood from entering the tip of the catheter when the catheter is not in use. As a secondary mechanism of action, it acts as an in vitro anticoagulant. This dual action decreases the risk of clot formation, consequently thrombolytic occlusions and by extension decreases the risk of CLABSI.

Also known as: KiteLock™ 4% Sterile Catheter Lock Solution

open label

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Presence of a tunneled central venous catheter or peripherally inserted central catheter (PICC) for administration of PN or intravenous hydration fluids to treat intestinal failure
• Patients aged 3 months to 18 years old inclusive
• Minimum patient weight of at least 5 kilograms
• History of at least one thrombolytic occlusion and/or CLABSI event
• Signed patient informed consent
• Clinically stable for at least 4 weeks with no acute medical co-morbidities

You may not qualify if:

• Pregnancy or nursing mother
• Enrollment in any other clinical trial involving an investigational agent (unless approved by the principal investigators of the other trial)
• The parent or guardian or child unwilling to provide consent or assent
• Clinical instability such as the following:
• Acute pulmonary edema
• Acute myocardial infarction
• Acute stroke
• Acute thromboembolism
• Metabolic acidosis
• Sepsis
• Coagulopathy with prolonged activated partial thromboplastin time (aPTT) or international normalized ratio (INR)
• Severe hypoglycemia
• Subjects who are hypersensitive or allergic to EDTA
• Active therapy with long-term anti-microbial agents, such as taurolidine (not including patients receiving intermittent antimicrobial treatment for small intestinal bacterial overgrowth)
• A compromised catheter defined as one which has been repaired several times.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• SterileCare Inc.: collaborator

Study Sites (1)

Childrens's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (17)

• Safdar N, Kluger DM, Maki DG. A review of risk factors for catheter-related bloodstream infection caused by percutaneously inserted, noncuffed central venous catheters: implications for preventive strategies. Medicine (Baltimore). 2002 Nov;81(6):466-79. doi: 10.1097/00005792-200211000-00007.

  PMID: 12441903 BACKGROUND

• Clare A, Teubner A, Shaffer JL. What information should lead to a suspicion of catheter sepsis in HPN? Clin Nutr. 2008 Aug;27(4):552-6. doi: 10.1016/j.clnu.2008.04.013. Epub 2008 Jul 26.

  PMID: 18662842 BACKGROUND

• Reimund JM, Arondel Y, Finck G, Zimmermann F, Duclos B, Baumann R. Catheter-related infection in patients on home parenteral nutrition: results of a prospective survey. Clin Nutr. 2002 Feb;21(1):33-8. doi: 10.1054/clnu.2001.0500.

  PMID: 11884010 BACKGROUND

• Squires RH, Duggan C, Teitelbaum DH, Wales PW, Balint J, Venick R, Rhee S, Sudan D, Mercer D, Martinez JA, Carter BA, Soden J, Horslen S, Rudolph JA, Kocoshis S, Superina R, Lawlor S, Haller T, Kurs-Lasky M, Belle SH; Pediatric Intestinal Failure Consortium. Natural history of pediatric intestinal failure: initial report from the Pediatric Intestinal Failure Consortium. J Pediatr. 2012 Oct;161(4):723-8.e2. doi: 10.1016/j.jpeds.2012.03.062. Epub 2012 May 11.

  PMID: 22578586 BACKGROUND

• Toure A, Duchamp A, Peraldi C, Barnoud D, Lauverjat M, Gelas P, Chambrier C. A comparative study of peripherally-inserted and Broviac catheter complications in home parenteral nutrition patients. Clin Nutr. 2015 Feb;34(1):49-52. doi: 10.1016/j.clnu.2013.12.017. Epub 2014 Jan 3.

  PMID: 24439240 BACKGROUND

• Ross VM, Guenter P, Corrigan ML, Kovacevich D, Winkler MF, Resnick HE, Norris TL, Robinson L, Steiger E. Central venous catheter infections in home parenteral nutrition patients: Outcomes from Sustain: American Society for Parenteral and Enteral Nutrition's National Patient Registry for Nutrition Care. Am J Infect Control. 2016 Dec 1;44(12):1462-1468. doi: 10.1016/j.ajic.2016.06.028.

  PMID: 27908433 BACKGROUND

• Chang MI, Carlson SJ, Nandivada P, O'Loughlin AA, Potemkin AK, Cowan E, Mitchell PD, Gura KM, Puder M. Challenging the 48-Hour Rule-Out for Central Line-Associated Bloodstream Infections in the Pediatric Intestinal Failure Population: A Retrospective Pilot Study. JPEN J Parenter Enteral Nutr. 2016 May;40(4):567-73. doi: 10.1177/0148607114567897. Epub 2015 Jan 7.

  PMID: 25567785 BACKGROUND

• Stephens LC, Haire WD, Kotulak GD. Are clinical signs accurate indicators of the cause of central venous catheter occlusion? JPEN J Parenter Enteral Nutr. 1995 Jan-Feb;19(1):75-9. doi: 10.1177/014860719501900175.

  PMID: 7658605 BACKGROUND

• Mehall JR, Saltzman DA, Jackson RJ, Smith SD. Fibrin sheath enhances central venous catheter infection. Crit Care Med. 2002 Apr;30(4):908-12. doi: 10.1097/00003246-200204000-00033.

  PMID: 11940768 BACKGROUND

• Crowley AL, Peterson GE, Benjamin DK Jr, Rimmer SH, Todd C, Cabell CH, Reller LB, Ryan T, Corey GR, Fowler VG Jr. Venous thrombosis in patients with short- and long-term central venous catheter-associated Staphylococcus aureus bacteremia. Crit Care Med. 2008 Feb;36(2):385-90. doi: 10.1097/01.CCM.0B013E3181611F914.

  PMID: 18091541 BACKGROUND

• Raad II, Luna M, Khalil SA, Costerton JW, Lam C, Bodey GP. The relationship between the thrombotic and infectious complications of central venous catheters. JAMA. 1994 Apr 6;271(13):1014-6.

  PMID: 8139059 BACKGROUND

• Thornburg CD, Smith PB, Smithwick ML, Cotten CM, Benjamin DK Jr. Association between thrombosis and bloodstream infection in neonates with peripherally inserted catheters. Thromb Res. 2008;122(6):782-5. doi: 10.1016/j.thromres.2007.10.001. Epub 2007 Nov 13.

  PMID: 17997477 BACKGROUND

• Timsit JF, Farkas JC, Boyer JM, Martin JB, Misset B, Renaud B, Carlet J. Central vein catheter-related thrombosis in intensive care patients: incidence, risks factors, and relationship with catheter-related sepsis. Chest. 1998 Jul;114(1):207-13. doi: 10.1378/chest.114.1.207.

  PMID: 9674471 BACKGROUND

• Shanks RM, Donegan NP, Graber ML, Buckingham SE, Zegans ME, Cheung AL, O'Toole GA. Heparin stimulates Staphylococcus aureus biofilm formation. Infect Immun. 2005 Aug;73(8):4596-606. doi: 10.1128/IAI.73.8.4596-4606.2005.

  PMID: 16040971 BACKGROUND

• Modi BP, Jaksic T. Pediatric intestinal failure and vascular access. Surg Clin North Am. 2012 Jun;92(3):729-43, x. doi: 10.1016/j.suc.2012.03.012.

  PMID: 22595718 BACKGROUND

• Liu F, Hansra S, Crockford G, Koster W, Allan BJ, Blondeau JM, Lainesse C, White AP. Tetrasodium EDTA Is Effective at Eradicating Biofilms Formed by Clinically Relevant Microorganisms from Patients' Central Venous Catheters. mSphere. 2018 Nov 28;3(6):e00525-18. doi: 10.1128/mSphere.00525-18.

  PMID: 30487154 BACKGROUND

• Hirsch TI, Fligor SC, Tsikis ST, Mitchell PD, DeVietro A, Carbeau S, Wang SZ, McClelland J, Carey AN, Gura KM, Puder M. Administration of 4% tetrasodium EDTA lock solution and central venous catheter complications in high-risk pediatric patients with intestinal failure: A retrospective cohort study. JPEN J Parenter Enteral Nutr. 2024 Jul;48(5):624-632. doi: 10.1002/jpen.2644. Epub 2024 Jun 5.

  PMID: 38837803 RESULT

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

• Mark Puder, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate, Department of Surgery. Professor of Surgery, Harvard Medical School

Model Details: Assessment of the effect of treatment will be based on a compassionate use study of parenterally administered 4% T-EDTA lock solution (KiteLock™ 4% Sterile Catheter Lock Solution) to determine safety and preliminary efficacy in the prevention of (1) thrombolytic occlusions, (2) catheter breakage and (3) CLABSI events. Each patient will serves as their own control with the catheter history 12 months' prior for each patient pre KiteLock ™ use (i.e., breakages, occlusions, CLABSIs) being compared with KiteLock ™ experience.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 22, 2020
• Study Start: December 21, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: To be determined.
• Access Criteria: To be determined.

Locations

US (1)