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To assess the efficacy of Taurolock-hep500â„¢ as anticoagulant and antimicrobial catheter lock solution in comparison to unfractionated heparin as alock solution to improve performance of hemodialysis catheters and quality of hemodialysis .
In this study,investigators will recruit 60 patients with ESRD on regular hemodialysis from hemodialysis units in Ain-Shams university Hospitals, Patients will be recruited to study at the time of catheter insertion.
They will be randomized into 2 groups. Group 1; 30 Patients will receive unfractionated heparin (5000i.u/ml) after hemodialysis sessions (control group).
Group 2; 30 Patients will receive Taurolock-hep500â„¢ after hemodialysis sessions. All patients will be subjected to;
Patients will be followed up for one month and will be monitored for clinical symptoms and signs of catheter related bacteremia (fever ,rigors, hypotension, sweating ) on the hemodialysis sessions . Also catheter performance will be assessed using the following parameters;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cases | Experimental | Cases, taurolidine heparin 500 will be used at end of session |
|
| control | Active Comparator | Controls, Heparin Sodium 5000 will be given at end of session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurolidine heparin | Drug | Taurolock-hep 500 at end of session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of inflammation in hemodialysis patients through hemodialysis catheters | Comparing levels of highly sensitive c-reactive protein and interleukin-6 levels before and after using the drug Urea reduction ratio over sessions | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magdy Sharkawy, MD | Contact | 002010-014-22331 | Magdi35@hotmail.com | |
| Amr Mansour, Msc | Contact | 00201007212824 | Theamr19@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Magdy Sharkawy, MD | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Recruiting | Cairo | 002 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | FOGARTY, DAMIAN, and PETER MAXWELL. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 9, 2019 | |
| Unrelease | Jan 13, 2019 | |
| Release | Jan 13, 2019 | |
| Reset | Apr 5, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 9, 2019 | Jan 13, 2019 | |||
| Jan 13, 2019 |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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comparative
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| Heparin Sodium | Drug | Heparin sodium 5000 at end of session |
|
|
| Apr 5, 2019 |