Taurolock Hep 500 Versus Unfractionated Heparin as Anti-inflammatory in Hemodialysis Catheters.
Keywords
Abstract
Description
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-hep500™ after hemodialysis sessions. All patients will be subjected to;
1. Full history including history of ESRD and dialysis initiation.
2. Clinical examination. Aseptic technique will be used in handling with catheters including (sterile gloves, antiseptic solution in dealing with covers and caps topical antibiotics spray and ointment) catheter will be instilled by 10 ml of normal saline in both opening followed by either taurolock hep 500™ or unfractionated heparin 5000 iu/ml.
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;
1. Blood flow rate measured by hemodialysis machine blood pump in (ml/min).
2. Dialysis quality by URR( urea reduction ratio) is a dimensionless number used to quantify dialysis treatment adequacy by calculating difference between urea level before and after hemodialysis session (average of 4 sessions , 1 per each week).
3. CBC ,markers of inflammation (CRP) baseline and at time of appearance of symptoms and signs of bacteremia in both groups in addition to (IL6) measured by Elisa technique baseline and at time of appearance of symptoms and signs .
Dates
| Last Verified: | 04/30/2018 |
| First Submitted: | 07/30/2017 |
| Estimated Enrollment Submitted: | 05/15/2018 |
| First Posted: | 05/28/2018 |
| Last Update Submitted: | 05/15/2018 |
| Last Update Posted: | 05/28/2018 |
| Actual Study Start Date: | 05/14/2018 |
| Estimated Primary Completion Date: | 10/31/2018 |
| Estimated Study Completion Date: | 01/31/2019 |
Condition or disease
Intervention/treatment
Drug: cases
Drug: control
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: cases Cases, taurolidine heparin 500 will be used at end of session | Drug: cases Taurolock-hep 500 at end of session |
| Active Comparator: control Controls, Heparin Sodium 5000 will be given at end of session | Drug: control Heparin sodium 5000 at end of session |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Patients on regular hemodialysis 3sessions/wk. 2. Recent catheter insertion at beginning of the study. 3. Both males and females. 4. Age group ≥ 18 ys. Exclusion Criteria: 1. Patients with intercurrent infections. 2. Patients with sepsis. 3. Patients receiving drugs affecting immune system like immunosuppressive drugs. 4. Patients on antibiotics. |
Outcome
Primary Outcome Measures
1. Prevention of inflammation in hemodialysis patients through hemodialysis catheters [one month]
