MedPath

Mupirocin 2% Ointment Vs Spray Antibiotics on Temporary Hemodialysis Catheter

Phase 2
Completed
Conditions
Hemodialysis Complication
Hemodialysis Catheter Infection
Interventions
Drug: Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU
Registration Number
NCT05874219
Lead Sponsor
Future University in Egypt
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
Inclusion Criteria

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

Exclusion Criteria
  • Age below 16
  • Noncompliance patients
  • Mechanical complications

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Local antibiotic sprayLocal antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IULocal antibiotic spray (n=75) The intervention Sprayed 1 to 3 times /day for 45 day Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU Bivatracin Spray
Mupirocin 2% ointmentMupirocin 2% ointment(The standard) 10 mm of mupirocin ointment squeezed directly on to their exit sites from a 15 g tube with an outlet diameter of 5 mm mupirocin 2% ointment
Primary Outcome Measures
NameTimeMethod
Catheter related infection45 days

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

Secondary Outcome Measures
NameTimeMethod
The average duration of HD catheter45 days

The average duration of HD catheter

Trial Locations

Locations (1)

Transplantation Clinic Nasser Institute

🇪🇬

Cairo, Egypt

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