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| Name | Class |
|---|---|
| Dr. Richard Whitlock | UNKNOWN |
| Dr. Julian Owen | UNKNOWN |
| Pamela Benoit, RN | UNKNOWN |
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Intravenous catheters are often placed in large (central) veins in critically ill patients to provide special medications or frequent blood sampling. The body reacts to the presence of foreign material by forming a biofilm on the surface within the catheter. Either due to the patients condition or to emergency access to these intravenous lines can become infected with bacteria and reside within the biofilm. When bacteria is grown from these lines it is referred to as: a central line infection. A medical device company (ICU Medical) has obtained the rights to a device that delivers a controlled amount of a cleaning material called chlorhexidine into the catheter to prevent bacterial growth when not in use. Chlorhexidine is the standard cleaning material used on patients when cleaning the skin for surgical procedures or central intravenous catheter insertion. In laboratory tests and animal studies that chlorhexidine inhibits the growth of bacteria and fungi that often cause central line infections. This study will the first assessment in patients with central lines.
Randomization Randomization will be determined using an online random number generator. "www.randomize.net". The research coordinator will randomize the patients and provide bedside staff with the devices when appropriate.
Intervention
Eligible patients that have provided informed consent will be randomized to receive:
Test Protocol
For patients randomized to the CHG-LockTM device, attach a attach a BD Posiflush ⢠0.9% Sodium Chloride (Na Cl) 10ml syringe and a CHG-Lock⢠device for each IV line that is to be locked. Follow hospital approved protocol for flush, volumes and hand hygiene (see appendix I, II and III).
After a Catheter has been locked, before re-accessing the catheter for further sampling or infusions, all fluid should be aspirated from the catheter to clear the device of CHG, Heparin and the like. This should also confirm patency of the device.
Discard the syringe and device in biohazard waste.
"Blue Cap" the IV as per routine practice.
Duration of intervention:
Measures to be taken to ensure compliance:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiseptic device | Experimental | Patients who are randomized to receive the device will receive Chlorhexidine at a dose of 0.24-0.42 mg/installation into all intravenous lines. The intervention will be administered every 24 hrs and as needed for as long as the intravenous is in place |
|
| Routine Care | No Intervention | Patients who are randomized to routine care (no device, no intervention) will receive normal saline flush as per standard ICU care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine flush | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with the protocol | The investigators will consider our study successful if we achieve compliance of than 90% use of device for locking. | Through study completion, an average of 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteremia | Rates of bacteremia determined by blood cultures obtained through a central line | Through study completion, an average of 14 days |
| Bacteria colonization of central line | Central Line Colonization Testing will be completed when the investigators are able to obtain the discontinued central line catheters for Electron Microscopy examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Fox-Robichaud, MD | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26903338 | Result | Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. | |
| 18418495 |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
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An Open Label Randomized Feasibility Pilot Study
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| Through study completion, an average of 14 days |
| Result |
| Holton D, Paton S, Conly J, Embree J, Taylor G, Thompson W. Central venous catheter-associated bloodstream infections occurring in Canadian intensive care units: A six-month cohort study. Can J Infect Dis Med Microbiol. 2006 May;17(3):169-76. doi: 10.1155/2006/781735. |
| 25331552 | Result | Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. doi: 10.1007/s15010-014-0689-y. Epub 2014 Oct 21. |
| 35856588 | Derived | Pook M, Zamir N, McDonald E, Fox-Robichaud A. Chlorhexidine (di)gluconate locking device for central line infection prevention in intensive care unit patients: a multi-unit, pilot randomized controlled trial. Br J Nurs. 2022 Jul 21;31(14):S36-S46. doi: 10.12968/bjon.2022.31.14.S36. |
| 32099661 | Derived | Zamir N, Pook M, McDonald E, Fox-Robichaud AE. Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial. Pilot Feasibility Stud. 2020 Feb 18;6:26. doi: 10.1186/s40814-020-0564-9. eCollection 2020. |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |