Antimicrobial Anticoagulant Antibiofilm
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Study Overview
Results from a pragmatic randomized controlled trial to evaluate the effectiveness of 4% t-EDTA in preventing CVAD-associated infections, occlusions, and thrombolytic use in adults treated in an intensive care unit (ICU).
Primary Endpoint
A composite incidence rate of CVAD-associated bloodstream infection (CLABSI), catheter occlusion requiring alteplase use, and/or catheter removal due to occlusion.
Patient Population
ICU patients aged >18 years with CVADs in place and at least 1 lumen not in use.
Sites
6 Canadian hospitals, including 3 community hospitals and 3 academic centers.
Follow Up & Median Length of Stay
Until ICU discharge, death, or the end of the treatment maintenance period. The median length of ICU stay during the study period was 6 days across medical-surgical ICUs (and only 3 days in the cardiac surgery center)
n = 1468
Patients Included
n = 722 Control*
6318 CDs
n = 696 t-EDTA
5654 CDs
*Normal Saline 0.9%; 4% Sodium Citrate HD Catheters;
CD = Catheter Days
Most Commonly Used CVADs
Other
11.4%
Triple Lumen
PICC
5.8%
Trialysis Catheter
6.9%
Hemodialysis
Catheter
10.3%
Triple Lumen
CVC
65.6%
Protocol Compliance
85.7%
1258 patients maintained ≥ 80% adherence to the study proposal
(n = 613, 88% with t-EDTA; n = 645, 84%, 319 control
Results: Primary Outcome Met
Primary Outcome Incidence Rate
Incidence per 1000 CD
0
5
10
15
20
25
13.1
19.9
34%
fewer events
*p= 0.03
Significantly fewer instances of CLABSI, catheter occlusion requiring alteplase use, and catheter removal due to occlusion were observed with t-EDTA vs control (p= 0.03)*
*In adjusted multivariate analysis of the composite primary outcome
t-EDTA
Control
Secondary Outcomes
0
5
10
15
20
CVAD occlusion requiring administration of alteplase significantly differed in favor of t-EDTA*
CLABSI*
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Obstruction Requiring Alteplase​
CVAD Removal Due to Occlusion
0.35
0.47
11.67
17.73
1.06
1.74
*The small number of CLABSI limits interpretability of this secondary outcome.
*rate ratio = 0.66
[95% CI: 0.46-0.96]
Safety
No adverse events, serious adverse events, or hypocalcemia related to t-EDTA or control
locking fluid use were reported during the study period.
Liu et al. 2018 https://pubmed.ncbi.nlm.nih.gov/30487154/
Refer to the IFU for Full Safety and Prescribing Information: https://sterilecareinc.com/wp-content/uploads/2025/11/GI_SC001_Catheter-Lock-Solution-3-mL_CA_006-00462_V06_K02.pdf
This information is intended for healthcare professionals and qualified scientific audiences for educational and scientific exchange purposes only.
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