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

Sponsor
Alison Fox-Robichaud (Other)
Overall Status
Completed
CT.gov ID
NCT03309137
Collaborator
Dr. Richard Whitlock (Other), Dr. Julian Owen (Other), Pamela Benoit, RN (Other)
100
Enrollment
1
Location
2
Arms
36.4
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Chlorhexidine flush
 N/A

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.

  1. Discard the syringe and device in biohazard waste.

  2. "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

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
An Open Label Randomized Feasibility Pilot StudyAn 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 :
Nov 19, 2017
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

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
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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Compliance with the protocol [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hamilton Health Sciences Hamilton Ontario Canada L8L 2X2

    Sponsors and Collaborators

    • Alison Fox-Robichaud
    • Dr. Richard Whitlock
    • Dr. Julian Owen
    • Pamela Benoit, RN

    Investigators

    • Principal Investigator: Alison Fox-Robichaud, MD, Hamilton Health Sciences Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Oct 13, 2017
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alison Fox-Robichaud, Professor McMaster University and Director of Medical Education at HHS, Hamilton Health Sciences Corporation
    Blood stream infections
    Prospective
    Preventative
    Randomized
    Additional relevant MeSH terms:
    Bacteremia
    Chlorhexidine

    Study Results

    No Results Posted as of May 5, 2022