Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05874219 |
| Other study ID # |
FMASU R85/2023 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
April 10, 2023 |
| Est. completion date |
May 25, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Future University in Egypt |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
