Comparison of Effectiveness and Complications of Catheter Lock Solutions in Non-tunneled Hemodialysis Catheters

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Effectiveness and Complications of Heparin and Sodium Bicarbonate Catheter Lock Solutions in Non-Tunneled Hemodialysis Catheters

Conditions
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Catheter Blockage, Catheter-Related Infections, Dialysis Catheter; Thrombosis, Catheter Infection, Catheter Related Complication, Catheter Dysfunction

Intervention / Treatment
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* Drug: Sodium bicarbonate
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients over 18 years who assign consent will be included Exclusion Criteria: patients less than 18 years of age Patients with active arterial or venous thrombosis problems Thrombocytopenic patients Patients with hypercoagulable states Patients with contraindications to heparin usage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Bicarbonate vs Heparin group (femoral vs jugular catheter)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium bicarbonate Arm<br>In this arm, the catheter lock solution is sodium bicarbonate | Drug: Sodium bicarbonate<br>* 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.<br>|
| Active Comparator: Heparin arm<br>In this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution) | Drug: Heparin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin, catheter lock solution, sodium bicarbonate, Non-tunneled dialysis catheter