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Device for Bacteremia Prevention in Post Cardiac Surgical Intensive Care Unit Patients (CHG-Lock™)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309137
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Dr. Richard Whitlock
Dr. Julian Owen
Pamela Benoit, RN
Information provided by (Responsible Party):
Alison Fox-Robichaud, Hamilton Health Sciences Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Infection Heart; Surgery, Heart, Functional Disturbance as Result Bacteremia Device: Chlorhexidine flush Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An Open Label Randomized Feasibility Pilot Study
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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
  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.
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Bacteremia [ Time Frame: Through study completion, an average of 14 days ]
    Rates of bacteremia determined by blood cultures obtained through a central line

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-100 year old adult patients admitted to the ICU;
  2. Same-day admit to ICU;
  3. Post-op patient with central lines in situ (PICC, multi-lumen, side arm of introducer catheters or temporary dialysis lines), AND;
  4. Expected to have at least 1 central line in situ for more than 72 hrs.

Exclusion Criteria:

  1. >24hrs post-admittance to ICU
  2. Hopeless prognosis
  3. Currently admitted with known infection or suspicion of infection (i.e. known endocarditis or other infections).
  4. Chronic indwelling central venous catheters present
  5. Patients with known allergies to chlorhexidine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309137


Contacts
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Contact: Alison Fox-Robichaud, MD 905 521 2100 ext 40742 afoxrob@mcmaster.ca
Contact: Ellen McDonald, RN 905 521 2100 ext 40787 emcdonal@mcmaster.ca

Locations
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Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Alison Fox-Robichaud, MD    905 521 2100 ext 40742    afoxrob@mcmaster.ca   
Contact: Ellen McDonald, RN    905 521 2100 ext 40787    emcdonal@mcmaster.ca   
Sponsors and Collaborators
Alison Fox-Robichaud
Dr. Richard Whitlock
Dr. Julian Owen
Pamela Benoit, RN
Investigators
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Principal Investigator: Alison Fox-Robichaud, MD Hamilton Health Sciences Corporation
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alison Fox-Robichaud, Professor McMaster University and Director of Medical Education at HHS, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03309137    
Other Study ID Numbers: 3654
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alison Fox-Robichaud, Hamilton Health Sciences Corporation:
Blood stream infections
Prospective
Preventative
Randomized
Additional relevant MeSH terms:
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Bacteremia
Infection
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants