Device for Bacteremia Prevention in Post Cardiac Surgical Intensive Care Unit Patients (CHG-Lock™)
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|ClinicalTrials.gov Identifier: NCT03309137|
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infection Heart; Surgery, Heart, Functional Disturbance as Result Bacteremia||Device: Chlorhexidine flush||Not Applicable|
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.
Eligible patients that have provided informed consent will be randomized to receive:
- Steril-flow® (CHG-Lock™) device OR
- Usual care
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.
- There is no need to use the CHG-Lock™ device for IV lines with IV solutions infusing or those attached to an IV pressure bag, to maintain IV patency.
- If the Central Line IV is blocked, access is done by withdraw 2-3 ml discard of blood, flush with 20 mls.
- If a line is blocked, do not force, the order must be obtained for Cathflo and administered by a certified Cathflo nurse.
- A CHG-Lock™ device will be applied with every intravenous flush for patients in the Active (CHG-LockTM ) arm.
- Bedside nurses will be educated on the use of the CHG-Lock™ device.
- The device will be used for every central line and peripheral IV instillation.
- All locking solutions must be removed prior to access. This is standard of practice.
- Bedside nurses will be asked to document application of the device and instillation in the medication profile.
- Pre-printed Physician Order Set will be created to ensure compliance with device use and protocol.
- A box with devices will be placed at the bedside to ensure ease of access for nurses and that patients receive the device at every lock episode.
Duration of intervention:
- The intervention will be used while the central line or peripheral IV remains in situ.
- The intervention will be discontinued when the patient leaves the ICU or the IV is discontinued.
Measures to be taken to ensure compliance:
- Study boxes labeled with patient name and ID at the bedside.
- Staff education (see 3.13)
- Daily oversight by research coordinator/Assistant
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||An Open Label Randomized Feasibility Pilot Study|
|Masking:||None (Open Label)|
|Official Title:||CHG-Lock™ Device for Bacteremia Prevention in Cardiac Surgical Intensive Care Unit Patients: An Open Label Randomized Feasibility Pilot Study|
|Actual Study Start Date :||November 19, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||November 30, 2019|
Experimental: Antiseptic device
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
Other Name: CHG-Lock™
No Intervention: Routine Care
Patients who are randomized to routine care (no device, no intervention) will receive normal saline flush as per standard ICU care.
- Compliance with the protocol [ Time Frame: Through study completion, an average of 14 days ]The investigators will consider our study successful if we achieve compliance of than 90% use of device for locking.
- Bacteremia [ Time Frame: Through study completion, an average of 14 days ]Rates of bacteremia determined by blood cultures obtained through a central line
- Bacteria colonization of central line [ Time Frame: Through study completion, an average of 14 days ]Central Line Colonization Testing will be completed when the investigators are able to obtain the discontinued central line catheters for Electron Microscopy examination
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309137
|Contact: Alison Fox-Robichaud, MD||905 521 2100 ext firstname.lastname@example.org|
|Contact: Ellen McDonald, RN||905 521 2100 ext email@example.com|
|Principal Investigator:||Alison Fox-Robichaud, MD||Hamilton Health Sciences Corporation|