InfectionCHG-Lock™NCT03309137
Device for Bacteremia Prevention in Post Cardiac Surgical Intensive Care Unit Patients
A study testing Chlorhexidine flush in people with Infection and Heart; Surgery, Heart, Functional Disturbance as Result, run by Alison Fox-Robichaud at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Infection, Heart; Surgery, Heart, Functional Disturbance as Result, Bacteremia
- What is being tested?
- Chlorhexidine flush
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 19 Nov 2017to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-100 year old adult patients admitted to the ICU;
- Same-day admit to ICU;
- Post-op patient with central lines in situ (PICC, multi-lumen, side arm of introducer catheters or temporary dialysis lines), AND;
- Expected to have at least 1 central line in situ for more than 72 hrs.
Who cannot join
- >24hrs post-admittance to ICU
- Hopeless prognosis
- Currently admitted with known infection or suspicion of infection (i.e. known endocarditis or other infections).
- Chronic indwelling central venous catheters present
- Patients with known allergies to chlorhexidine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Steril-flow® (CHG-Lock™) device OR
- Usual care
Test Protocol
- 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
- Being tested
- Chlorhexidine flush
- Keywords
- Blood stream infections, Prospective, Preventative, Randomized
- Medical subject headings
- Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine flushDevice
Also called CHG-Lock™
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Antiseptic device | Experimental | 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 Receives: Device: Chlorhexidine flush |
| Routine Care | No intervention | Patients who are randomized to routine care (no device, no intervention) will receive normal saline flush as per standard ICU care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with the protocol
The investigators will consider our study successful if we achieve compliance of than 90% use of device for locking.
Measured: Through study completion, an average of 14 days
Secondary outcomes (2)
Bacteremia
Rates of bacteremia determined by blood cultures obtained through a central line
Measured: Through study completion, an average of 14 days
Bacteria colonization of central line
Central Line Colonization Testing will be completed when the investigators are able to obtain the discontinued central line catheters for Electron Microscopy examination
Measured: Through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start19 Nov 2017
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An Open Label Randomized Feasibility Pilot Study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alison Fox-Robichaud
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Richard Whitlock, Dr. Julian Owen, Pamela Benoit, RN
- Responsible party
- Sponsor-investigator, Alison Fox-Robichaud, Hamilton Health Sciences Corporation
- Investigators
- Alison Fox-Robichaud, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309137
- Sponsor's protocol ID
- 3654
- Acronym
- CHG-Lock™
- Status last verified
- May 2022
- First submitted
- 19 Sep 2017
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Holton D, Paton S, Conly J, Embree J, Taylor G, Thompson W. Central venous catheter-associated bloodstream infections occurring in Canadian intensive care units: A six-month cohort study. Can J Infect Dis Med Microbiol. 2006 May;17(3):169-76. doi: 10.1155/2006/781735.
PubMed 18418495Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. doi: 10.1007/s15010-014-0689-y. Epub 2014 Oct 21.
PubMed 25331552Pook M, Zamir N, McDonald E, Fox-Robichaud A. Chlorhexidine (di)gluconate locking device for central line infection prevention in intensive care unit patients: a multi-unit, pilot randomized controlled trial. Br J Nurs. 2022 Jul 21;31(14):S36-S46. doi: 10.12968/bjon.2022.31.14.S36.
PubMed 35856588Zamir N, Pook M, McDonald E, Fox-Robichaud AE. Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial. Pilot Feasibility Stud. 2020 Feb 18;6:26. doi: 10.1186/s40814-020-0564-9. eCollection 2020.
PubMed 32099661
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHG-Lock™ Device for Bacteremia Prevention in Cardiac Surgical Intensive Care Unit Patients: An Open Label Randomized Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT03309137
- Acronym / sponsor ID
- CHG-Lock™ / 3654
- Keywords
- Blood stream infections, Prospective, Preventative, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alison Fox-RobichaudUniversity, hospital or other
- Collaborators
- Dr. Richard Whitlock, Dr. Julian Owen, Pamela Benoit, RN
- Study start
- 19 Nov 2017 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Steril-flow® (CHG-Lock™) device OR
- Usual care
Test Protocol
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An Open Label Randomized Feasibility Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Antiseptic device | Experimental | Device: Chlorhexidine flushPatients 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 |
| Routine Care | No intervention | –Patients who are randomized to routine care (no device, no intervention) will receive normal saline flush as per standard ICU care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-100 year old adult patients admitted to the ICU;
- Same-day admit to ICU;
- Post-op patient with central lines in situ (PICC, multi-lumen, side arm of introducer catheters or temporary dialysis lines), AND;
- Expected to have at least 1 central line in situ for more than 72 hrs.
Key exclusion criteria (5 listed)
- >24hrs post-admittance to ICU
- Hopeless prognosis
- Currently admitted with known infection or suspicion of infection (i.e. known endocarditis or other infections).
- Chronic indwelling central venous catheters present
- Patients with known allergies to chlorhexidine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine flushAlso: CHG-Lock™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. | Device | Antiseptic device |
Primary outcome
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.
2 secondary outcomes
Bacteremia
Time frame: Through study completion, an average of 14 days
Bacteria colonization of central line
Time frame: Through study completion, an average of 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Results publication: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Results publication: PubMed 18418495Holton D, Paton S, Conly J, Embree J, Taylor G, Thompson W. Central venous catheter-associated bloodstream infections occurring in Canadian intensive care units: A six-month cohort study. Can J Infect Dis Med Microbiol. 2006 May;17(3):169-76. doi: 10.1155/2006/781735.
- Results publication: PubMed 25331552Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. doi: 10.1007/s15010-014-0689-y. Epub 2014 Oct 21.
- Derived from this study: PubMed 35856588Pook M, Zamir N, McDonald E, Fox-Robichaud A. Chlorhexidine (di)gluconate locking device for central line infection prevention in intensive care unit patients: a multi-unit, pilot randomized controlled trial. Br J Nurs. 2022 Jul 21;31(14):S36-S46. doi: 10.12968/bjon.2022.31.14.S36.
- Derived from this study: PubMed 32099661Zamir N, Pook M, McDonald E, Fox-Robichaud AE. Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial. Pilot Feasibility Stud. 2020 Feb 18;6:26. doi: 10.1186/s40814-020-0564-9. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Fox-Robichaud, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine flush in people with Infection and Heart; Surgery, Heart, Functional Disturbance as Result, run by Alison Fox-Robichaud at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with the protocol (time frame: Through study completion, an average of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309137, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.