Catheter Blockage, Catheter Dysfunction, Catheter Infection, Catheter Related Complication, Catheter-Related Infections, Dialysis Catheter; Thrombosis
Conditions
Keywords
catheter lock solution, sodium bicarbonate, heparin, Non-tunneled dialysis catheter
Brief summary
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
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.
Interventions
DRUGSodium bicarbonate
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.
DRUGHeparin
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.
Sponsors
Cumhuriyet University
Sisli Hamidiye Etfal Training and Research Hospital
Zonguldak Ataturk State Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Bicarbonate vs Heparin group (femoral vs jugular catheter)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Causes of premature catheter malfunction | 6 months | any catheter needing exchange prematurly will be be evaluated for mulfunction cause (etiher mechanical thromus or kink rtc.) |
| Number of patients with catheter related infection | 6 months | any catheter related infection(exit site, lumen inection etc) will be recorded |
| Time of catheter occlusion or failure | 6 months | catheteres occluded by thrombi will be documented |
| Time to first catheter failure (day) | 6 months | The time from first sucessful dialysis session to the last one (in days) |
| Total Duration of catheter usage (day) | 6 months | 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 |
| Number of participants with catheter occlusion | 6 months | The number of cases early catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of cases with venous thrombosis | 6 months | 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. |
| Total number of dialysis sessions with active patent catheter usage | 6 months | In some cases intensive treatment is indicated. the effect of frequent usage of catheteres will be evaluated |
Countries
Turkey (Türkiye)
Outcome results
None listed