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| Name | Class |
|---|---|
| Cumhuriyet University | OTHER |
| Sisli Hamidiye Etfal Training and Research Hospital | OTHER |
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In our study, investigators will investigate the effectiveness and complications of two catheter lock solutions one of which is the standard heparin routinely used in comparison to Sodium bicarbonate. Both solutions were used but not compared head to head. Investigators aim to compare both solutions in terms of catheter lumen patency and their effect on catheter-related infections.
The most important problem in patients with end-stage renal disease or patients with acute renal failure needing urgent hemodialysis treatment is the lack of appropriate vascular access. In acute situations, vascular access is usually provided by non-tunneled catheters. Main problems with this temporaray vascular access is failure due to lumen thrombosis. anther major problem is catheter related infection. In some patients, there is a handicap of using heparin. In some situations, heparin is not preferred for use. In terms of the probable shortage of resources and cost-effectiveness, Investigators aimed to compare head to head the superiority and non-inferiority of each solution. Sodium bicarbonate was compared to the isotonic solution and found to be effective for a short time. The main aim of this study is to compare both classic Heparin and sodium bicarbonate in Femoral and Jugular catheters aimed for dialysis. In both arms, the maximum patency and the observed side effects will be recorded. The maximal time used will be recorded. statistical analysis will be planned to compare the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium bicarbonate Arm | Active Comparator | In this arm, the catheter lock solution is sodium bicarbonate |
|
| Heparin arm | Active Comparator | In this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | Dialysis catheter lumen will be filled (locked) by sodium bicarbonate solution. The amount of solution depends on the diameter and length and will be in accordance with the manufacturer's specifications. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first catheter failure (day) | The time from first sucessful dialysis session to the last one (in days) | 6 months |
| Total Duration of catheter usage (day) | some patients need only 1-2 dialysis sessions while others may need too many sessions. In some cases a total of three dialysi sessions is whithin 3-4 days while others may need that number in wider range (e.g 10-14 days). Here both number and duraion effect is evaluated | 6 months |
| Number of participants with catheter occlusion | The number of cases early catheter | 6 months |
| Number of patients with catheter related infection | any catheter related infection(exit site, lumen inection etc) will be recorded | 6 months |
| Time of catheter occlusion or failure | catheteres occluded by thrombi will be documented | 6 months |
| Causes of premature catheter malfunction | any catheter needing exchange prematurly will be be evaluated for mulfunction cause (etiher mechanical thromus or kink rtc.) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of dialysis sessions with active patent catheter usage | In some cases intensive treatment is indicated. the effect of frequent usage of catheteres will be evaluated | 6 months |
| Number of cases with venous thrombosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MAHMUD M ISLAM, MD | Zonguldak Ataturk State Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cumhuriyet University Hospital | Sivas | TN | 34762 | Turkey (Türkiye) | ||
| Zonguldak ataturk state hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30668833 | Background | El-Hennawy AS, Frolova E, Romney WA. Sodium bicarbonate catheter lock solution reduces hemodialysis catheter loss due to catheter-related thrombosis and blood stream infection: an open-label clinical trial. Nephrol Dial Transplant. 2019 Oct 1;34(10):1739-1745. doi: 10.1093/ndt/gfy388. | |
| 37823971 | Derived | Islam M. Sodium bicarbonate is a potential alternative to classic heparin as a lock solution for non-tunneled dialysis catheters: a result from the prospective randomized BicarbLock trial. Int Urol Nephrol. 2024 Apr;56(4):1465-1474. doi: 10.1007/s11255-023-03821-9. Epub 2023 Oct 12. |
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The study protocol and methods will be available in a paper intended for publication, any materials or data may be available on demand
Starting in February 2021 ends in September 2021
The inquired information will be sent by e-mail
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Bicarbonate vs Heparin group (femoral vs jugular catheter)
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| Heparin | Drug | Dialysis catheter lumen will be filled (locked) by classic heparin. The amount of pure heparin depends on the diameter and length and will be in accordance with the manufacturer's specifications. |
|
catheters especially femoral have a risk of venous thrombosis, any clincal sign of thrombosis will be recorded. In case of catheter removal doppler ultrasound will be documented.
| 6 months |
| Zonguldak |
| TN |
| 67100 |
| Turkey (Türkiye) |
| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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