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

NCT04967859 | Completed Phase 1 DMC

• 1 other identifier: 98328718.0.0000.5411
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Catheter Infection

Keywords

hemodialysis;; tunneled catheter; central venous catheters; infections; prevention.

Outcome Measures

Primary Outcomes (2)

• Rates of exit-site infection

  Rates of exit-site infection (measured in events per 1,000 catheter-days)

  1 years

• Rates of catheter-related bloodstream infections

  Rates of catheter-related bloodstream infections (measured in events per 1,000 catheter-days)

  1 years

Study Arms (2)

Group 1 (control):

PLACEBO COMPARATOR

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

Drug: Placebo

Group 2 (intervention)

EXPERIMENTAL

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

Drug: 0.1% gentamicin

Interventions

0.1% gentamicin DRUG

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

Group 2 (intervention)

Placebo DRUG

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

Group 1 (control):

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Universidade Estadual Paulista Júlio de Mesquita Filho

Botucatu, São Paulo, 18.618-970, Brazil

Location

Related Publications (10)

• 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.

  PMID: 26498416 BACKGROUND

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

  PMID: 23859190 BACKGROUND

• 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.

  PMID: 18413621 BACKGROUND

• Zacharioudakis IM, Zervou FN, Arvanitis M, Ziakas PD, Mermel LA, Mylonakis E. Antimicrobial lock solutions as a method to prevent central line-associated bloodstream infections: a meta-analysis of randomized controlled trials. Clin Infect Dis. 2014 Dec 15;59(12):1741-9. doi: 10.1093/cid/ciu671. Epub 2014 Aug 25.

  PMID: 25156111 BACKGROUND

• 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.

  PMID: 27039404 BACKGROUND

• 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.

  PMID: 24278133 BACKGROUND

• 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.

  PMID: 24125729 BACKGROUND

• 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.

  PMID: 20227787 BACKGROUND

• 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.

  PMID: 18498236 BACKGROUND

• 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.

  PMID: 24970878 BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Gentamicins

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Daniela Ponce

  Universidade Estadual Paulista Júlio de Mesquita Filho

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be allocated to two groups randomly (draw), according to the prescribed topical treatment (gentamicin or placebo). The randomization protocol will be generated by an individual other than the patients' clinical follow-up using specific software (randomization). . The randomization list as well as the identification of the bottles and the uniformity of the packages will remain under the care of the researchers who are not familiar with the patients' clinical follow-up
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group 1 (control): Patients using placebo ointment in ES Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: July 20, 2021
• Study Start: July 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: July 1, 2020
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)