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Completed

NCT Number: NCT05874219

Mupirocin 2% Ointment Vs Spray Antibiotics on Temporary Hemodialysis Catheter

In dialysis centers, many patients are undergoing hemodialysis simultaneously, which facilitates the spread of microorganisms by direct or indirect contact through the devices, equipment, surface contact, and hands of health profession Over time, catheters are prone to higher rates of infection, thrombosis, and central venous stenosis, it has also been shown that catheters are an independent (of infection) inflammatory stressor and lead to increased morbidity .

Catheters are aptly referred to as a bacterial highway, and a biofilm formation around the catheter is often the breeding ground of bacteria and fungi, which can easily spread to the bloodstream Infectious complications are the most serious with regards to patient morbidity and mortality. The incidence could be from 3.8 to5.5 episodes per 1000 days

Migration of micro-organism along the external surface of the catheter is probably the most common route of infection through skin and represents 58% .HD catheter has biofilm formation on their surfaces and this serves as a good reservoir for micro-organisms

Most patients with end stage renal disease (ESRD) starting hemodialysis through hemodialysis catheter about 9 % in Egypt and most of them require several hemodialysis catheters before maturation of arterio -venous fistula and even after stopping it.

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Key information

Conditions

Hemodialysis Complication Hemodialysis Catheter Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Transplantation Clinic Nasser Institute

Cairo, Egypt

About this study

Patients receiving hemodialysis have a high risk of infection due to the immunosuppressive effects caused by ESRD, comorbidities, inadequate nutrition and the need for maintenance of vascular access for long periods.

The catheters are rightfully the least preferred modality and, in an ideal setting, no patient should have a catheter as access. Despite the perils associated with dialysis catheters, their use has increased to almost 70% incident dialysis initiation with catheters In dialysis centers, many patients are undergoing hemodialysis simultaneously, which facilitates the spread of microorganisms by direct or indirect contact through the devices, equipment, surface contact, and hands of health profession Over time, catheters are prone to higher rates of infection, thrombosis, and central venous stenosis, it has also been shown that catheters are an independent (of infection) inflammatory stressor and lead to increased morbidity Catheters are aptly referred to as a bacterial highway, and a biofilm formation around the catheter is often the breeding ground of bacteria and fungi, which can easily spread to the bloodstream Infectious complications are the most serious with regards to patient morbidity and mortality. The incidence could be from 3.8 to5.5 episodes per 1000 days

Migration of micro-organism along the external surface of the catheter is probably the most common route of infection through skin and represents 58% .HD catheter has biofilm formation on their surfaces and this serves as a good reservoir for micro-organisms

Most patients with end stage renal disease (ESRD) starting hemodialysis through hemodialysis catheter about 9 % in Egypt and most of them require several hemodialysis catheters before maturation of arterio -venous fistula and even after stopping it.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Adults patients receiving long-term hemodialysis using temporary right internal jugular hemodialysis catheter

Exclusion criteria

  • Age below 16
  • Noncompliance patients
  • Mechanical complications

Treatment and study plan

Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU

Drug

The intervention Sprayed 1 to 3 times /day

Other names: BIVATRACIN

Mupirocin 2% ointment

Drug

10 mm of mupirocin ointment squeezed directly on to their exit sites from a 15 g tube with an outlet diameter of 5 mm

Primary outcomes

  1. Catheter related infection

    Time frame: 45 days

    Catheter related infection which will manifest by fever rigor and obligatory remove of the catheter.

Secondary outcomes

  1. The average duration of HD catheter

    Time frame: 45 days

    The average duration of HD catheter

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

The Effect of Mupirocin 2% Ointment on the Duration of Stay of Temporary Hemodialysis Catheter Compared to Other Spray Antibiotics

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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