The Effects of Anti-infective Central Venous Catheter on Catheter-related Infection in Critically Patients

NCT ID: NCT02645682

Last Updated: 2017-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1818 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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anti-infection CVC (Certofix®protect)

intervention group

Group Type EXPERIMENTAL

anti-infection CVC

Intervention Type DEVICE

normal CVC (Certofix®)

control group

Group Type ACTIVE_COMPARATOR

normal CVC

Intervention Type DEVICE

Interventions

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anti-infection CVC

Intervention Type DEVICE

normal CVC

Intervention Type DEVICE

Other Intervention Names

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Certofix®protect Certofix®

Eligibility Criteria

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Inclusion Criteria

* adult patients in intensive care unit (ICU)(age ≥ 18 years)
* needs double lumen CVC more than 5 days
* Signed informed consent

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kang Yan

professor; chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Kang, Doctor

Role: STUDY_CHAIR

West China Hospital

Bin Du, Doctor

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Kang, Doctor

Role: CONTACT

(+86)189-8060-1566

Yao Chen, Doctor

Role: CONTACT

(+86)153-0808-8233

Facility Contacts

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Bin Du, Doctor

Role: primary

Yan Kang, Doctor

Role: primary

(+86)189-8060-1566

Yao Chen, Doctor

Role: backup

(+86)153-0808-8233

References

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Reference Type BACKGROUND
PMID: 21511081 (View on PubMed)

Cicalini 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.

Reference Type BACKGROUND
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Saint 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.

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 24009330 (View on PubMed)

Halton 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.

Reference Type BACKGROUND
PMID: 19284570 (View on PubMed)

Maki 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.

Reference Type BACKGROUND
PMID: 9265424 (View on PubMed)

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Reference Type BACKGROUND
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Rupp 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.

Reference Type BACKGROUND
PMID: 16230723 (View on PubMed)

Gong P, Li H, He X, et al. Preparation and antibacterial activity of Fe3O4@Ag nanoparticles. Nanotechnology 2007; 18: 604-11

Reference Type BACKGROUND

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Reference Type BACKGROUND
PMID: 37016550 (View on PubMed)

Samuel 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.

Reference Type BACKGROUND
PMID: 15037331 (View on PubMed)

Hsu 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.

Reference Type BACKGROUND
PMID: 20542329 (View on PubMed)

Lai 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.

Reference Type BACKGROUND
PMID: 23740696 (View on PubMed)

Campisi 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

Reference Type BACKGROUND

Cortelezzi A, Moia M, Falanga A, Pogliani EM, Agnelli G, Bonizzoni E, Gussoni G, Barbui T, Mannucci PM; CATHEM Study Group. Incidence of thrombotic complications in patients with haematological malignancies with central venous catheters: a prospective multicentre study. Br J Haematol. 2005 Jun;129(6):811-7. doi: 10.1111/j.1365-2141.2005.05529.x.

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PMID: 21366477 (View on PubMed)

Monreal M, Raventos A, Lerma R, Ruiz J, Lafoz E, Alastrue A, Llamazares JF. Pulmonary embolism in patients with upper extremity DVT associated to venous central lines--a prospective study. Thromb Haemost. 1994 Oct;72(4):548-50.

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Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S-e496S. doi: 10.1378/chest.11-2301.

Reference Type BACKGROUND
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Mehall JR, Saltzman DA, Jackson RJ, Smith SD. Fibrin sheath enhances central venous catheter infection. Crit Care Med. 2002 Apr;30(4):908-12. doi: 10.1097/00003246-200204000-00033.

Reference Type BACKGROUND
PMID: 11940768 (View on PubMed)

Raad II, Luna M, Khalil SA, Costerton JW, Lam C, Bodey GP. The relationship between the thrombotic and infectious complications of central venous catheters. JAMA. 1994 Apr 6;271(13):1014-6.

Reference Type BACKGROUND
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Pierce CM, Wade A, Mok Q. Heparin-bonded central venous lines reduce thrombotic and infective complications in critically ill children. Intensive Care Med. 2000 Jul;26(7):967-72. doi: 10.1007/s001340051289.

Reference Type BACKGROUND
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Wu M, Chen Y, Du B, Kang Y. Study protocol for a multicentre, randomised, controlled trial to assess the effectiveness of antimicrobial central venous catheters versus ordinary central venous catheters at reducing catheter related infections in critically ill Chinese patients. BMJ Open. 2017 Dec 29;7(12):e016564. doi: 10.1136/bmjopen-2017-016564.

Reference Type DERIVED
PMID: 29289933 (View on PubMed)

Other Identifiers

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HC-I-H 1503

Identifier Type: -

Identifier Source: org_study_id

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