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

May 3, 2022 updated by: Alison Fox-Robichaud

CHG-Lock™ Device for Bacteremia Prevention in Cardiac Surgical Intensive Care Unit Patients: An Open Label Randomized Feasibility Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacteremia
Time Frame: Through study completion, an average of 14 days
Rates of bacteremia determined by blood cultures obtained through a central line
Through study completion, an average of 14 days
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
Through study completion, an average of 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alison Fox-Robichaud

Collaborators

Dr. Richard Whitlock
Dr. Julian Owen
Pamela Benoit, RN

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2017

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

October 9, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3654

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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