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AzTrials

Hemodialysis Catheter InfectionPhase 1NCT04967859

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

A Phase 1 study testing 0.1% gentamicin in people with Hemodialysis Catheter Infection, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hemodialysis Catheter Infection
What is being tested?
0.1% gentamicin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteBrazil
Study dates
1 Jul 2018to 1 Jul 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Estadual Paulista Júlio de Mesquita Filho

    Botucatu, São Paulo, 18.618-970

Other trials in Brazil

About this study

Official title: Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis: a Randomized, Double-blind Clinical Trial

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.

Read the 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.

Being tested
0.1% gentamicin, Placebo
Keywords
hemodialysis;, tunneled catheter, central venous catheters, infections, prevention.
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.1% gentamicinDrug

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

  • PlaceboDrug

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

Study groups in NCT04967859
Study groupRoleWhat they receive
Group 1 (control):Placebo comparatorPatients using placebo ointment at the exit site of the hemodialysis catheter
Receives: Drug: Placebo
Group 2 (intervention)ExperimentalPatient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter
Receives: Drug: 0.1% gentamicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rates of exit-site infection

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

    Measured: 1 years

  2. Rates of catheter-related bloodstream infections

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

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start1 Jul 2018
  3. Primary completion1 Nov 2019
  4. Study completion1 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group 1 (control): Patients using placebo ointment in ES Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04967859
Sponsor's protocol ID
98328718.0.0000.5411
Status last verified
Jul 2021
First submitted
30 Nov 2018
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26498416

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

    PubMed 23859190

  • 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.

    PubMed 18413621

  • 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.

    PubMed 25156111

  • 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.

    PubMed 27039404

  • 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.

    PubMed 24278133

  • 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.

    PubMed 24125729

  • 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.

    PubMed 20227787

  • 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.

    PubMed 18498236

  • 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.

    PubMed 24970878

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 0.1% gentamicin in people with Hemodialysis Catheter Infection, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of exit-site infection (time frame: 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04967859, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.

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