Device for Bacteremia Prevention in Post Cardiac Surgical Intensive Care Unit Patients
Condition: Infection; Heart; Surgery, Heart, Functional Disturbance as Result; Bacteremia
MeSH terms: Bacteremia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. Steril-flow® (CHG-Lock™) device OR

        2. Usual care

      Test Protocol

        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 (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.

        2. Discard the syringe and device in biohazard waste.

        3. "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:

        1. Study boxes labeled with patient name and ID at the bedside.

        2. Staff education (see 3.13)

        3. Daily oversight by research coordinator/Assistant
    

Intervention name(s): Chlorhexidine flush
Intervention type(s): Device
Intervention description(s): 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.
Discard the syringe and device in biohazard waste.
"Blue Cap" the IV as per routine practice.
Other intervention name(s): CHG-Lock™
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An Open Label Randomized Feasibility Pilot Study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Blood stream infections; Prospective; Preventative; Randomized