Critical IllnessNCT02645682
The Effects of Anti-infective Central Venous Catheter on Catheter-related Infection in Critically Patients
A study testing anti-infection CVC and normal CVC in people with Critical Illness, run by West China Hospital at 2 sites in China.
Trial summary
The purpose of this study is to investigate the effect of anti-infective central venous catheter(Certofix®Protect) on reducing catheter-related bloodstream infection in critically ill patients in China, and the relationship between catheter-related bloodstream infection and catheter-related thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- anti-infection CVC and normal CVC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,818 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2016to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients in intensive care unit (ICU)（age ≥ 18 years）
- needs double lumen CVC more than 5 days
- Signed informed consent
Who cannot join
- thrombosis in target and/or contralateral vein
- pregnancy or lactating women
- unlikely to survive for more than 1 month
- bad prognosis
- suspected catheter-related infection
- replacement CVC in original site through guide wire
Show all 10Show fewer
- severe burn
- situation that is not suitable for CVC, including allergic to CVC material, thrombosis in target vein, infection of puncture site, coagulation disorder, abnormal anatomy
- already in this study
- participated in other studies within 3 months
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Bin Du, Doctor
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Yan Kang, Doctor, (+86)189-8060-1566, kangyan_hx@163.com
Yao Chen, Doctor, (+86)153-0808-8233, 314351895@qq.com
About this study
Official title: The Effects of Anti-infective Central Venous Catheter(CVC) on Catheter-related Bloodstream Infection(CRBSI) in Critical Care Patients: a Multiple-center, Randomized, Control Study
The purpose of this study is to investigate the effect of anti-infective central venous catheter(Certofix®Protect) on reducing catheter-related bloodstream infection in critically ill patients in China, and the relationship between catheter-related bloodstream infection and catheter-related thrombosis.
- Conditions
- Critical Illness
- Being tested
- anti-infection CVC, normal CVC
- Keywords
- central venous catheter (CVC), catheter-related bloodstream infection (CRBSI), catheter-related thrombosis (CRT)
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-infection CVCDevice
Also called Certofix®protect
normal CVCDevice
Also called Certofix®
| Study group | Role | What they receive |
|---|---|---|
| anti-infection CVC (Certofix®protect) | Experimental | intervention group Receives: Device: anti-infection CVC |
| normal CVC (Certofix®) | Active comparator | control group Receives: Device: normal CVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
catheter-related bloodstream infection
number of participants with catheter-related bloodstream infection
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
catheter-related thrombosis
number of participants with catheter-related thrombosis
Measured: through study completion, an average of 2 years
all cause mortality
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 1,818 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Kang Yan, West China Hospital
- Investigators
- Yan Kang, Doctor, Study chair, West China HospitalBin Du, Doctor, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645682
- Sponsor's protocol ID
- HC-I-H 1503
- Status last verified
- May 2017
- First submitted
- 30 Dec 2015
- Last updated
- 10 May 2017
- Results posted
- No
Publications
O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
PubMed 21511081Cicalini S, Palmieri F, Petrosillo N. Clinical review: new technologies for prevention of intravascular catheter-related infections. Crit Care. 2004 Jun;8(3):157-62. doi: 10.1186/cc2380. Epub 2003 Sep 29.
PubMed 15153233Saint S, Veenstra DL, Lipsky BA. The clinical and economic consequences of nosocomial central venous catheter-related infection: are antimicrobial catheters useful? Infect Control Hosp Epidemiol. 2000 Jun;21(6):375-80. doi: 10.1086/501776.
PubMed 10879567中华医学会重症医学分会。血管内导管相关感染的预防与治疗指南。中国实用外科杂志2008; 28: 413-21
Rupp ME. Central venous catheters coated or impregnated with antimicrobial agents effectively prevent microbial colonisation and catheter-related bloodstream infections. Evid Based Med. 2014 Apr;19(2):56. doi: 10.1136/eb-2013-101471. Epub 2013 Sep 5. No abstract available.
PubMed 24009330Halton KA, Cook DA, Whitby M, Paterson DL, Graves N. Cost effectiveness of antimicrobial catheters in the intensive care unit: addressing uncertainty in the decision. Crit Care. 2009;13(2):R35. doi: 10.1186/cc7744. Epub 2009 Mar 11.
PubMed 19284570Maki DG, Stolz SM, Wheeler S, Mermel LA. Prevention of central venous catheter-related bloodstream infection by use of an antiseptic-impregnated catheter. A randomized, controlled trial. Ann Intern Med. 1997 Aug 15;127(4):257-66. doi: 10.7326/0003-4819-127-4-199708150-00001.
PubMed 9265424Raad I, Darouiche R, Dupuis J, Abi-Said D, Gabrielli A, Hachem R, Wall M, Harris R, Jones J, Buzaid A, Robertson C, Shenaq S, Curling P, Burke T, Ericsson C. Central venous catheters coated with minocycline and rifampin for the prevention of catheter-related colonization and bloodstream infections. A randomized, double-blind trial. The Texas Medical Center Catheter Study Group. Ann Intern Med. 1997 Aug 15;127(4):267-74. doi: 10.7326/0003-4819-127-4-199708150-00002.
PubMed 9265425Rupp ME, Lisco SJ, Lipsett PA, Perl TM, Keating K, Civetta JM, Mermel LA, Lee D, Dellinger EP, Donahoe M, Giles D, Pfaller MA, Maki DG, Sherertz R. Effect of a second-generation venous catheter impregnated with chlorhexidine and silver sulfadiazine on central catheter-related infections: a randomized, controlled trial. Ann Intern Med. 2005 Oct 18;143(8):570-80. doi: 10.7326/0003-4819-143-8-200510180-00007.
PubMed 16230723Kvitek L, Soukupova J. Comment on 'Preparation and antibacterial activity of Fe3O4@Ag nanoparticles'. Nanotechnology. 2009 Jan 14;20(2):028001. doi: 10.1088/0957-4484/20/2/028001. Epub 2008 Dec 11.
PubMed 19417286Shrivastava S, Bera T, Roy A, Singh G, Ramachandrarao P, Dash D. Retracted: Characterization of enhanced antibacterial effects of novel silver nanoparticles. Nanotechnology. 2007 May 4;18(22). doi: 10.1088/0957-4484/18/22/225103.
PubMed 37016550Samuel U, Guggenbichler JP. Prevention of catheter-related infections: the potential of a new nano-silver impregnated catheter. Int J Antimicrob Agents. 2004 Mar;23 Suppl 1:S75-8. doi: 10.1016/j.ijantimicag.2003.12.004.
PubMed 15037331Hsu SH, Tseng HJ, Lin YC. The biocompatibility and antibacterial properties of waterborne polyurethane-silver nanocomposites. Biomaterials. 2010 Sep;31(26):6796-808. doi: 10.1016/j.biomaterials.2010.05.015. Epub 2010 Jun 12.
PubMed 20542329Lai NM, Chaiyakunapruk N, Lai NA, O'Riordan E, Pau WS, Saint S. Catheter impregnation, coating or bonding for reducing central venous catheter-related infections in adults. Cochrane Database Syst Rev. 2013 Jun 6;(6):CD007878. doi: 10.1002/14651858.CD007878.pub2.
PubMed 23740696Campisi C, Biffi R, Pittiruti M. Catheter-related venous thrombosis: the development of a nationwide consensus paper in Italy. J AssocVasc Access 2007; 12: 38-46
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Anti-infective Central Venous Catheter(CVC) on Catheter-related Bloodstream Infection(CRBSI) in Critical Care Patients: a Multiple-center, Randomized, Control Study
- ClinicalTrials.gov ID
- NCT02645682
- Acronym / sponsor ID
- HC-I-H 1503
- Conditions
- Critical Illness
- Keywords
- central venous catheter (CVC), catheter-related bloodstream infection (CRBSI), catheter-related thrombosis (CRT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,818 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Jan 2016 (estimated)
- 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.
The purpose of this study is to investigate the effect of anti-infective central venous catheter(Certofix®Protect) on reducing catheter-related bloodstream infection in critically ill patients in China, and the relationship between catheter-related bloodstream infection and catheter-related thrombosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-infection CVC (Certofix®protect) | Experimental | Device: anti-infection CVCintervention group |
| normal CVC (Certofix®) | Active comparator | Device: normal CVCcontrol group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients in intensive care unit (ICU)（age ≥ 18 years）
- needs double lumen CVC more than 5 days
- Signed informed consent
Key exclusion criteria (10 listed)
- thrombosis in target and/or contralateral vein
- pregnancy or lactating women
- unlikely to survive for more than 1 month
- bad prognosis
- suspected catheter-related infection
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 |
|---|---|---|
| anti-infection CVCAlso: Certofix®protect | Device | anti-infection CVC (Certofix®protect) |
| normal CVCAlso: Certofix® | Device | normal CVC (Certofix®) |
Primary outcome
catheter-related bloodstream infection
Time frame: through study completion, an average of 2 years
number of participants with catheter-related bloodstream infection
2 secondary outcomes
catheter-related thrombosis
Time frame: through study completion, an average of 2 years
all cause mortality
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Background: PubMed 21511081O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
- Background: PubMed 15153233Cicalini S, Palmieri F, Petrosillo N. Clinical review: new technologies for prevention of intravascular catheter-related infections. Crit Care. 2004 Jun;8(3):157-62. doi: 10.1186/cc2380. Epub 2003 Sep 29.
- Background: PubMed 10879567Saint S, Veenstra DL, Lipsky BA. The clinical and economic consequences of nosocomial central venous catheter-related infection: are antimicrobial catheters useful? Infect Control Hosp Epidemiol. 2000 Jun;21(6):375-80. doi: 10.1086/501776.
- Background中华医学会重症医学分会。血管内导管相关感染的预防与治疗指南。中国实用外科杂志2008; 28: 413-21
- Background: PubMed 24009330Rupp ME. Central venous catheters coated or impregnated with antimicrobial agents effectively prevent microbial colonisation and catheter-related bloodstream infections. Evid Based Med. 2014 Apr;19(2):56. doi: 10.1136/eb-2013-101471. Epub 2013 Sep 5. No abstract available.
- Background: PubMed 19284570Halton KA, Cook DA, Whitby M, Paterson DL, Graves N. Cost effectiveness of antimicrobial catheters in the intensive care unit: addressing uncertainty in the decision. Crit Care. 2009;13(2):R35. doi: 10.1186/cc7744. Epub 2009 Mar 11.
- Background: PubMed 9265424Maki DG, Stolz SM, Wheeler S, Mermel LA. Prevention of central venous catheter-related bloodstream infection by use of an antiseptic-impregnated catheter. A randomized, controlled trial. Ann Intern Med. 1997 Aug 15;127(4):257-66. doi: 10.7326/0003-4819-127-4-199708150-00001.
- Background: PubMed 9265425Raad I, Darouiche R, Dupuis J, Abi-Said D, Gabrielli A, Hachem R, Wall M, Harris R, Jones J, Buzaid A, Robertson C, Shenaq S, Curling P, Burke T, Ericsson C. Central venous catheters coated with minocycline and rifampin for the prevention of catheter-related colonization and bloodstream infections. A randomized, double-blind trial. The Texas Medical Center Catheter Study Group. Ann Intern Med. 1997 Aug 15;127(4):267-74. doi: 10.7326/0003-4819-127-4-199708150-00002.
- Background: PubMed 16230723Rupp ME, Lisco SJ, Lipsett PA, Perl TM, Keating K, Civetta JM, Mermel LA, Lee D, Dellinger EP, Donahoe M, Giles D, Pfaller MA, Maki DG, Sherertz R. Effect of a second-generation venous catheter impregnated with chlorhexidine and silver sulfadiazine on central catheter-related infections: a randomized, controlled trial. Ann Intern Med. 2005 Oct 18;143(8):570-80. doi: 10.7326/0003-4819-143-8-200510180-00007.
- Background: PubMed 19417286Kvitek L, Soukupova J. Comment on 'Preparation and antibacterial activity of Fe3O4@Ag nanoparticles'. Nanotechnology. 2009 Jan 14;20(2):028001. doi: 10.1088/0957-4484/20/2/028001. Epub 2008 Dec 11.
- Background: PubMed 37016550Shrivastava S, Bera T, Roy A, Singh G, Ramachandrarao P, Dash D. Retracted: Characterization of enhanced antibacterial effects of novel silver nanoparticles. Nanotechnology. 2007 May 4;18(22). doi: 10.1088/0957-4484/18/22/225103.
- Background: PubMed 15037331Samuel U, Guggenbichler JP. Prevention of catheter-related infections: the potential of a new nano-silver impregnated catheter. Int J Antimicrob Agents. 2004 Mar;23 Suppl 1:S75-8. doi: 10.1016/j.ijantimicag.2003.12.004.
- Related InfoLink provided by the sponsor.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Yan Kang, Doctor study chair
West China Hospital
Bin Du, Doctor study chair
Peking Union Medical College Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-infection CVC and normal CVC in people with Critical Illness, run by West China Hospital at 2 sites in China.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Kang, Doctor ((+86)189-8060-1566, kangyan_hx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catheter-related bloodstream infection (time frame: through study completion, an average of 2 years). 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 NCT02645682, which also lists 23 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 10 May 2017.