Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis

NCT ID: NCT04967859

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-07-01

Brief Summary

Chronic kidney disease (CKD) is a major public health problem worldwide, with a significant increase in the number of patients treated with dialysis and renal transplantation. Hemodialysis (HD) is the most widely used dialysis therapy in the world, and adequate vascular access is required. The central venous catheter (CVC), although not considered the ideal vascular access, is still widely used. Its use has a strong relation with access-related infection, whether it is an exit orifice (IES), a tunnel and the most severe, the bloodstream (BSI). Consequently CVC contributes to patients' morbidity and mortality in HD, as well as to the high cost of hemodialysis treatment.

To compare the use of 0.1% topical gentamicin with the use of placebo in the exit site (ES) of tunneled catheters in patients in chronic HD regarding the reduction in IES and BSI rates and to identify the induction of bacterial resistance to gentamicin.

Detailed Description

A randomized, double-blind clinical trial comparing the use of 0.1% gentamicin versus placebo in the ES of tunnelled catheters for hemodialysis in the prevalence and density of incidence of IES and BSI. Patients will be allocated into two groups randomly: Group 1 (control): Patients using placebo ointment in ES; Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES.

Conditions

Hemodialysis Catheter Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1 (control):

Patients using placebo ointment at the exit site of the hemodialysis catheter

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients using placebo ointment at the exit site of the hemodialysis catheter

Group 2 (intervention)

Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter

Group Type: EXPERIMENTAL

0.1% gentamicin

Intervention Type: DRUG

Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter

Interventions

0.1% gentamicin

Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter

Intervention Type: DRUG

Placebo

Patients using placebo ointment at the exit site of the hemodialysis catheter

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• incident and prevalent patients on hemodialysis
• Tunnelled catheter implant within 90 days of study initiation

Exclusion Criteria

• patients under 18 years of age
• pregnant women
• other types of access for dialysis other than tunnelled catheters
• course of infection at the time of initiation of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Camille Pereira Caetano

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Ponce

Role: STUDY_DIRECTOR

Universidade Estadual Paulista Júlio de Mesquita Filho

Locations

Universidade Estadual Paulista Júlio de Mesquita Filho

Botucatu, São Paulo, Brazil

Countries

Brazil

References

National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015.

Reference Type: BACKGROUND

PMID: 26498416 (View on PubMed)

Camins BC. Prevention and treatment of hemodialysis-related bloodstream infections. Semin Dial. 2013 Jul-Aug;26(4):476-81. doi: 10.1111/sdi.12117.

Reference Type: BACKGROUND

PMID: 23859190 (View on PubMed)

James MT, Conley J, Tonelli M, Manns BJ, MacRae J, Hemmelgarn BR; Alberta Kidney Disease Network. Meta-analysis: antibiotics for prophylaxis against hemodialysis catheter-related infections. Ann Intern Med. 2008 Apr 15;148(8):596-605. doi: 10.7326/0003-4819-148-8-200804150-00004.

Reference Type: BACKGROUND

PMID: 18413621 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25156111 (View on PubMed)

Wang Y, Ivany JN, Perkovic V, Gallagher MP, Woodward M, Jardine MJ. Anticoagulants and antiplatelet agents for preventing central venous haemodialysis catheter malfunction in patients with end-stage kidney disease. Cochrane Database Syst Rev. 2016 Apr 4;4(4):CD009631. doi: 10.1002/14651858.CD009631.pub2.

Reference Type: BACKGROUND

PMID: 27039404 (View on PubMed)

Liu Y, Zhang AQ, Cao L, Xia HT, Ma JJ. Taurolidine lock solutions for the prevention of catheter-related bloodstream infections: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2013 Nov 21;8(11):e79417. doi: 10.1371/journal.pone.0079417. eCollection 2013.

Reference Type: BACKGROUND

PMID: 24278133 (View on PubMed)

Zhao Y, Li Z, Zhang L, Yang J, Yang Y, Tang Y, Fu P. Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2014 Mar;63(3):479-90. doi: 10.1053/j.ajkd.2013.08.016. Epub 2013 Oct 11.

Reference Type: BACKGROUND

PMID: 24125729 (View on PubMed)

Snaterse M, Ruger W, Scholte Op Reimer WJ, Lucas C. Antibiotic-based catheter lock solutions for prevention of catheter-related bloodstream infection: a systematic review of randomised controlled trials. J Hosp Infect. 2010 May;75(1):1-11. doi: 10.1016/j.jhin.2009.12.017. Epub 2010 Mar 15.

Reference Type: BACKGROUND

PMID: 20227787 (View on PubMed)

Yahav D, Rozen-Zvi B, Gafter-Gvili A, Leibovici L, Gafter U, Paul M. Antimicrobial lock solutions for the prevention of infections associated with intravascular catheters in patients undergoing hemodialysis: systematic review and meta-analysis of randomized, controlled trials. Clin Infect Dis. 2008 Jul 1;47(1):83-93. doi: 10.1086/588667.

Reference Type: BACKGROUND

PMID: 18498236 (View on PubMed)

Landry D, Braden G. Reducing catheter-related infections in hemodialysis patients. Clin J Am Soc Nephrol. 2014 Jul;9(7):1156-9. doi: 10.2215/CJN.04700514. Epub 2014 Jun 26. No abstract available.

Reference Type: BACKGROUND

PMID: 24970878 (View on PubMed)

Other Identifiers

98328718.0.0000.5411

Identifier Type: -

Identifier Source: org_study_id