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
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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UNKNOWN
NA
1818 participants
INTERVENTIONAL
2016-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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anti-infection CVC (Certofix®protect)
intervention group
anti-infection CVC
normal CVC (Certofix®)
control group
normal CVC
Interventions
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anti-infection CVC
normal CVC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* needs double lumen CVC more than 5 days
* Signed informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
West China Hospital
OTHER
Responsible Party
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Kang Yan
professor; chief physician
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
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Bin Du, Doctor
Role: primary
References
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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.
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.
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.
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.
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.
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.
Raad 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.
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.
Gong P, Li H, He X, et al. Preparation and antibacterial activity of Fe3O4@Ag nanoparticles. Nanotechnology 2007; 18: 604-11
Shrivastava 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.
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.
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.
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.
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
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.
Kucher N. Clinical practice. Deep-vein thrombosis of the upper extremities. N Engl J Med. 2011 Mar 3;364(9):861-9. doi: 10.1056/NEJMcp1008740. No abstract available.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HC-I-H 1503
Identifier Type: -
Identifier Source: org_study_id
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