Central Venous Catheter ThrombosisCLiCKNCT04548713
CLiCK in the Critical Care Unit
A study testing 4% EDTA and Saline in people with Central Venous Catheter Thrombosis and Central Venous Catheter Related Bloodstream Infection, run by Fraser Health at 6 sites in Canada.
Trial summary
Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADss are prone to complications such as infection, bacterial biofilm production, and catheter occlusion due to a thrombus. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Central Venous Catheter Thrombosis, Central Venous Catheter Related Bloodstream Infection, Catheter Complications
- What is being tested?
- 4% EDTA and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,449 participants
- Where
- 6 sitesCanada
- Study dates
- 22 Mar 2022to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age ICU/HAU Admission
- Presence of a central venous catheter requiring locking. This includes CVCs, IVADs, dialysis lines, and PICC lines.
Who cannot join
- Known or tested sensitivity to EDTA or edetate
- Confirmed or suspected pregnancy
- Patients who decline receiving blood products
- Physician, patient, or temporary substitute decision maker (TSDM) declines
- Currently enrolled in any other research study that may confound primary outcome measures. Co-enrollment in multiple studies will be considered on an individual basis
- Patients who were previously enrolled in the study. Patients who were enrolled in the first period are not eligible for (re-)enrolment in the second period, and patients who are enrolled in the study and transferred to another participating hospital are not eligible for (re-)enrollment at the receiving hospital. Patients who had been discharged from the unit to another hospital ward and are re-admitted to the critical care unit are no eligible for re-enrollment into the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Burnaby Hospital
Burnaby, British Columbia, V5G 2X6
Nanaimo Regional General Hospital
Nanaimo, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia
Surrey Memoral Hospital
Surrey, British Columbia
Royal Jubilee Hospital
Victoria, British Columbia
St. Boniface Hospital
Winnipeg, Manitoba
About this study
Official title: Control of Line Complications With KiteLock (CLiCK) in the Critical Care Unit
Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADss are prone to complications such as infection, bacterial biofilm production, and catheter occlusion due to a thrombus. A CVAD is placed in up to 97% of patients in the intensive care unit, exposing this vulnerable population to risk of nosocomial infection and occlusion.
Current standard of care involves use of normal saline (for CVCs and PICCs) or citrate (for hemodialysis catheters) as a catheter locking solution. CVAD complications remain a problem with current standard of care.
Read more
4% tetrasodium Ethylenediaminetetraacetic acid (EDTA) fluid (KiteLock Sterile Locking Solution) possesses antimicrobial, anti-biofilm, and anti-thrombotic properties and is approved by Health Canada as a catheter locking solution. As such, it may be superior CVC locking solution than the present normal saline or citrate lock.
To our knowledge, the efficacy of an EDTA catheter locking solution has not yet been investigated in the intensive care patient population. Our team proposes to fill this knowledge gap by performing a multi-centre, cluster-randomized, crossover study evaluating the impact of KiteLock Sterile Locking Solution on a primary composite outcome of CLABSI, intraluminal occlusion, and alteplase use in the ICU of six ICU's compared to the standard of care saline lock.
- Conditions
- Central Venous Catheter Thrombosis, Central Venous Catheter Related Bloodstream Infection, Catheter Complications, Catheter Blockage, Catheter Dysfunction, Central Line-associated Bloodstream Infection (CLABSI)
- Being tested
- 4% EDTA, Saline
- Keywords
- Ethylenediaminetetraaceticacid
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% EDTADevice
Also called KiteLock 4% Sterile Catheter Lock Solution
Sterile Catheter Lock Solution
SalineDevice
Saline Lock Solution
| Study group | Role | What they receive |
|---|---|---|
| 4% EDTA CVC Lock | Experimental | Patients in this group will be given 4% EDTA as their CVC locking solution. Receives: Device: 4% EDTA |
| Standard of Care Saline CVC Lock | Active comparator | Patients in this group will be given standard of care saline as their CVC locking solution. Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures
incidence rate of the following: catheter obstruction requiring Alteplase, central-line associated bloodstream infection (CLABSI), or CVC replacement due to occlusion.
Measured: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months.
Secondary outcomes (7)
Incidence rate of confirmed/suspected CLABSI
Confirmed diagnosis of CLABSI as diagnosed by the patients healthcare team and on the patient chart.
Measured: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Incidence rate of catheter occlusion requiring removal
Confirmed occurrence of occlusion requiring removal as noted by the patients healthcare team and on the patient chart.
Measured: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Incidence rate of catheter obstruction requiring alteplase use
Confirmed obstruction requiring alteplase use as noted by the patients healthcare team and on the patient chart.
Measured: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Direct cost related to alteplase use for catheter occlusion
This outcome will be evaluated based on economical analysis.
Measured: through study From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months, an average of 16 months
Incidence rate of catheter-associated venous thrombosis
Confirmed occurrence of catheter-associated venous thrombosis as noted by the patients healthcare team and on the patient chart.
Measured: From date of randomization until the date of ICU discharge, patient death death, or through study completion, an average of 9 months
Incidence rate of catheter colonization
Confirmed occurrence of catheter colonization as noted by the patients healthcare team and on the patient chart.
Measured: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Classification of microbial species isolated from colonized catheters
A convenience sample of 15 colonized CVC's and 15 non-colonized CVC's (control) will be collected for further analysis as available.
Measured: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start22 Mar 2022
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Venous Catheter ThrombosisStudies 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
- Crossover
- Model description
- Multi-center, cluster-randomized, double-blinded, crossover study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- SterileCare Inc., Center for Health Evaluation & Outcome Services
- Responsible party
- Principal investigator, Steve Reynolds, Fraser Health
- Investigators
- Steven Reynolds, MD, Principal investigator, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548713
- Sponsor's protocol ID
- 0001
- Acronym
- CLiCK
- Status last verified
- Feb 2025
- First submitted
- 3 Sep 2020
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ornowska M, Wittmann J, Blitz S, Wong H, Vazquez-Grande G, Mitra AR, Jang W, Wood G, Ovakim D, Forrest D, Rohrs E, Reynolds S. 4% Tetrasodium EDTA to Prevent Central Venous Access Device-Associated Complications: A Randomized Clinical Trial. JAMA. 2026 Jun 23;335(24):2126-2134. doi: 10.1001/jama.2026.6025.
PubMed 42150112Ornowska M, Wong H, Ouyang Y, Mitra A, White A, Willems S, Wittmann J, Reynolds S. Control of Line Complications with KiteLock (CLiCK) in the critical care unit: study protocol for a multi-center, cluster-randomized, double-blinded, crossover trial investigating the effect of a novel locking fluid on central line complications in the critical care population. Trials. 2022 Aug 30;23(1):719. doi: 10.1186/s13063-022-06671-5.
PubMed 36042488
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Line Complications With KiteLock (CLiCK) in the Critical Care Unit
- ClinicalTrials.gov ID
- NCT04548713
- Acronym / sponsor ID
- CLiCK / 0001
- Conditions
- Central Venous Catheter Thrombosis, Central Venous Catheter Related Bloodstream Infection, Catheter Complications, Catheter Blockage, Catheter Dysfunction, Central Line-associated Bloodstream Infection (CLABSI)
- Keywords
- Ethylenediaminetetraaceticacid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,449 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- SterileCare Inc., Center for Health Evaluation & Outcome Services
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 14 Sep 2020 (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.
Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADss are prone to complications such as infection, bacterial biofilm production, and catheter occlusion due to a thrombus. A CVAD is placed in up to 97% of patients in the intensive care unit, exposing this vulnerable population to risk of nosocomial infection and occlusion.
Current standard of care involves use of normal saline (for CVCs and PICCs) or citrate (for hemodialysis catheters) as a catheter locking solution. CVAD complications remain a problem with current standard of care.
4% tetrasodium Ethylenediaminetetraacetic acid (EDTA) fluid (KiteLock Sterile Locking Solution) possesses antimicrobial, anti-biofilm, and anti-thrombotic properties and is approved by Health Canada as a catheter locking solution. As such, it may be superior CVC locking solution than the present normal saline or citrate lock.
To our knowledge, the efficacy of an EDTA catheter locking solution has not yet been investigated in the intensive care patient population. Our team proposes to fill this knowledge gap by performing a multi-centre, cluster-randomized, crossover study evaluating the impact of KiteLock Sterile Locking Solution on a primary composite outcome of CLABSI, intraluminal occlusion, and alteplase use in the ICU of six ICU's compared to the standard of care saline lock.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, cluster-randomized, double-blinded, crossover study.
| Arm | Type | Receives |
|---|---|---|
| 4% EDTA CVC Lock | Experimental | Device: 4% EDTAPatients in this group will be given 4% EDTA as their CVC locking solution. |
| Standard of Care Saline CVC Lock | Active comparator | Device: SalinePatients in this group will be given standard of care saline as their CVC locking solution. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age ICU/HAU Admission
- Presence of a central venous catheter requiring locking. This includes CVCs, IVADs, dialysis lines, and PICC lines.
Key exclusion criteria (6 listed)
- Known or tested sensitivity to EDTA or edetate
- Confirmed or suspected pregnancy
- Patients who decline receiving blood products
- Physician, patient, or temporary substitute decision maker (TSDM) declines
- Currently enrolled in any other research study that may confound primary outcome measures. Co-enrollment in multiple studies will be considered on an individual basis
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 |
|---|---|---|
| 4% EDTAAlso: KiteLock 4% Sterile Catheter Lock SolutionSterile Catheter Lock Solution | Device | 4% EDTA CVC Lock |
| SalineSaline Lock Solution | Device | Standard of Care Saline CVC Lock |
Primary outcome
Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures
Time frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months.
incidence rate of the following: catheter obstruction requiring Alteplase, central-line associated bloodstream infection (CLABSI), or CVC replacement due to occlusion.
7 secondary outcomes
Incidence rate of confirmed/suspected CLABSI
Time frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Incidence rate of catheter occlusion requiring removal
Time frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Incidence rate of catheter obstruction requiring alteplase use
Time frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Direct cost related to alteplase use for catheter occlusion
Time frame: through study From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months, an average of 16 months
Incidence rate of catheter-associated venous thrombosis
Time frame: From date of randomization until the date of ICU discharge, patient death death, or through study completion, an average of 9 months
Incidence rate of catheter colonization
Time frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Classification of microbial species isolated from colonized catheters
Time frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 42150112Ornowska M, Wittmann J, Blitz S, Wong H, Vazquez-Grande G, Mitra AR, Jang W, Wood G, Ovakim D, Forrest D, Rohrs E, Reynolds S. 4% Tetrasodium EDTA to Prevent Central Venous Access Device-Associated Complications: A Randomized Clinical Trial. JAMA. 2026 Jun 23;335(24):2126-2134. doi: 10.1001/jama.2026.6025.
- Derived from this study: PubMed 36042488Ornowska M, Wong H, Ouyang Y, Mitra A, White A, Willems S, Wittmann J, Reynolds S. Control of Line Complications with KiteLock (CLiCK) in the critical care unit: study protocol for a multi-center, cluster-randomized, double-blinded, crossover trial investigating the effect of a novel locking fluid on central line complications in the critical care population. Trials. 2022 Aug 30;23(1):719. doi: 10.1186/s13063-022-06671-5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Steven Reynolds, MD principal investigator
Fraser Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4% EDTA and Saline in people with Central Venous Catheter Thrombosis and Central Venous Catheter Related Bloodstream Infection, run by Fraser Health at 6 sites in Canada.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures (time frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months.). 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 NCT04548713, which also lists 2 linked publications.
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 28 Feb 2025.