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

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

Overview

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.

Interventions

• 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.
• Device Heparin Lock Solution
  Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.

Primary outcome measures

• Incidence of catheter occlusions [Time frame: 52 weeks]

Secondary outcome measures (5)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 8 centers

• Boston Children's Hospital — Boston
• University of Nebraska Medical Center — Omaha
• Nyph/Cumc — New York
• Duke University Medical Center — Durham
• Cincinnati Children's Hospital Medical Center — Cincinnati
• Nationwide Children's Hospital — Columbus
• Cook Children's Health Care System — Fort Worth
• Seattle Children's Hospital — Seattle

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: 10.1 PMID 32770561

Identifiers

NCT: NCT05879835 · CT23-001-SC001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗