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
Among 21 studies in Bacteremia with a site in Canada — 5 open to participants now, 6 under way, none of them phase 3. Bacteremia · Canada.
Among the 21 studies in Bacteremia with a site in Canada, this one is the 15th largest by enrollment of the 19 interventional ones, is one of 3 that started in 2017, is one of 12 with no phase, and was the 9th registered.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's enrollment of 100 is below the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →5 of the 21 studies in Bacteremia with a site in Canada are open now, in 5 countries. Each count lists the studies.
Of the 40 Bacteremia studies recruiting now, 32 (80%) set no upper age limit and 4 (10%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2017.
Median enrollment 200 across the 19 interventional studies, 350 across the 2 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.
None of the 21 has an industry lead sponsor. The 10 most frequent:
Alison Fox-Robichaud is the lead sponsor of 2 studies on the registry; none are open to participants now.
Alison Fox-Robichaud has 1 study filed under Bacteremia — fewer than ten, so there is no comparison to draw.
3 of the studies in Bacteremia with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03671967Rambam Health Care CampusPipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN) | 2027-01-01 |
| NCT04886284Todd C. Lee MD MPH FIDSACombination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia | 2027-04 |
| NCT06537609Sunnybrook Health Sciences CentreA Platform Trial for Gram Negative Bloodstream Infections | 2027-04 |
Among the 21 studies in Bacteremia with a site in Canada, from their registry updates:
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:
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's enrollment of 100 is below the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →Alison Fox-Robichaud is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Bacteremia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Ran from Nov 2017 to primary completion in Nov 2020, 36 months.
Of 34 non-industry interventional studies with no phase under Bacteremia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 64. This study's 36 months is close to that.
Counting every sponsor, half of 35 studies reached it within 34 months; a quarter within 13 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alison Fox-Robichaud