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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04548713
Other study ID # 0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2022
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Fraser Health
Contact Marlena Ornowska
Phone 2363326575
Email mornowsk@sfu.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1524
Est. completion date December 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - >18 years of age ICU/HAU Admission - Presence of a central venous catheter requiring locking. This includes CVCs, IVADs, dialysis lines, and PICC lines. Exclusion Criteria: - 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.

Study Design


Intervention

Device:
4% EDTA
Sterile Catheter Lock Solution
Saline
Saline Lock Solution

Locations

Country Name City State
Canada Burnaby Hospital Burnaby British Columbia
Canada Nanaimo Regional General Hospital Nanaimo British Columbia
Canada Royal Columbian Hospital New Westminster British Columbia
Canada Surrey Memoral Hospital Surrey British Columbia
Canada Royal Jubilee Hospital Victoria British Columbia
Canada St. Boniface Hospital Winnipeg Manitoba

Sponsors (3)

Lead Sponsor Collaborator
Fraser Health Center for Health Evaluation & Outcome Services, SterileCare Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Subgroup analysis Those with their CVAD in place for 7 days or more will be analyzed in a separate subgroup for primary and secondary outcomes From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Primary 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. 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 Incidence rate of confirmed/suspected CLABSI Confirmed diagnosis of CLABSI as diagnosed by the patients healthcare team and on the patient chart. 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 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. 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 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. 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 Direct cost related to alteplase use for catheter occlusion This outcome will be evaluated based on economical analysis. 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
Secondary 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. From date of randomization until the date of ICU discharge, patient death death, or through study completion, an average of 9 months
Secondary Incidence rate of catheter colonization Confirmed occurrence of catheter colonization as noted by the patients healthcare team and on the patient chart. 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 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. From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
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