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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
124
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.
Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.
Boston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
NOT_YET_RECRUITINGColumbia University Irving Medical Center
New York, New York, United States
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.
Time frame: 52 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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Duke University Medical Center
Durham, North Carolina, United States
RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGNationwide Children's Hospital
Columbus, Ohio, United States
RECRUITINGCook Children's Health Care System
Fort Worth, Texas, United States
RECRUITINGSeattle Children's Hospital
Seattle, Washington, United States
RECRUITINGTime frame: 52 weeks