An interventional study of Chlorhexidine flush in Infection, Heart; Surgery, Heart, Functional Disturbance as Result and Bacteremia, sponsored by Alison Fox-Robichaud. Completed at 1 site in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Alison Fox-Robichaud · Not applicable, Interventional, and Prevention
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.
"Blue Cap" the IV as per routine practice.
Duration of intervention:
Measures to be taken to ensure compliance:
Exclusion Criteria:
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
Device: Chlorhexidine flush
Patients who are randomized to routine care (no device, no intervention) will receive normal saline flush as per standard ICU care.
1. 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. 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. 2. Discard the syringe and device in biohazard waste. 3. "Blue Cap" the IV as per routine practice.
Also known as: CHG-Lock™
Compliance with the protocol
The investigators will consider our study successful if we achieve compliance of than 90% use of device for locking.
Time frame: Through study completion, an average of 14 days
Bacteremia
Rates of bacteremia determined by blood cultures obtained through a central line
Time frame: 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
Time frame: Through study completion, an average of 14 days
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Alison Fox-Robichaud