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

NCT02645682 | Unknown

• 1 other identifier: HC-I-H 1503
• Study Type: interventional
• Target: 1,818
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Critical Illness

Keywords

central venous catheter (CVC); catheter-related bloodstream infection (CRBSI); catheter-related thrombosis (CRT)

Outcome Measures

Primary Outcomes (1)

• catheter-related bloodstream infection

  number of participants with catheter-related bloodstream infection

  through study completion, an average of 2 years

Secondary Outcomes (2)

• catheter-related thrombosis

  through study completion, an average of 2 years

• all cause mortality

  through study completion, an average of 2 years

Study Arms (2)

anti-infection CVC (Certofix®protect)

EXPERIMENTAL

intervention group

Device: anti-infection CVC

normal CVC (Certofix®)

ACTIVE COMPARATOR

control group

Device: normal CVC

Interventions

anti-infection CVC DEVICE

Also known as: Certofix®protect

anti-infection CVC (Certofix®protect)

normal CVC DEVICE

Also known as: Certofix®

normal CVC (Certofix®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (23)

• 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.

  PMID: 21511081 BACKGROUND

• 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.

  PMID: 15153233 BACKGROUND

• 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.

  PMID: 10879567 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

• 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.

  PMID: 24009330 BACKGROUND

• 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.

  PMID: 19284570 BACKGROUND

• 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.

  PMID: 9265424 BACKGROUND

• 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.

  PMID: 9265425 BACKGROUND

• 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.

  PMID: 16230723 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 37016550 BACKGROUND

• 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.

  PMID: 15037331 BACKGROUND

• 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.

  PMID: 20542329 BACKGROUND

• 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.

  PMID: 23740696 BACKGROUND

• 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

  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.

  PMID: 15953009 BACKGROUND

• 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.

  PMID: 21366477 BACKGROUND

• 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.

  PMID: 7878630 BACKGROUND

• 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.

  PMID: 22315268 BACKGROUND

• 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.

  PMID: 11940768 BACKGROUND

• 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.

  PMID: 8139059 BACKGROUND

• 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.

  PMID: 10990114 BACKGROUND

• 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.

  PMID: 29289933 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Kang, Doctor

  West China Hospital

  STUDY CHAIR

• Bin Du, Doctor

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Yan Kang, Doctor

CONTACT

(+86)189-8060-1566; kangyan_hx@163.com

Yao Chen, Doctor

CONTACT

(+86)153-0808-8233; 314351895@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor; chief physician

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 5, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

CN (2)