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

Catheter-Related Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772209
• Other study ID #: ZADH-1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2023
• Source: Zonguldak Ataturk State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Blockage
• Catheter Dysfunction
• Catheter Infection
• Catheter Related Complication
• Catheter-Related Infections
• Communicable Diseases
• Dialysis Catheter; Thrombosis
• Infections
• Thrombosis

Intervention

Drug:
• Sodium 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.
• Heparin
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.

Locations

Country	Name	City	State
Turkey	Cumhuriyet University Hospital	Sivas	TN
Turkey	Zonguldak ataturk state hospital	Zonguldak	TN

Sponsors (3)

Lead Sponsor	Collaborator
Zonguldak Ataturk State Hospital	Cumhuriyet University, Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first catheter failure (day)	The time from first sucessful dialysis session to the last one (in days)	6 months
Primary	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
Primary	Number of participants with catheter occlusion	The number of cases early catheter	6 months
Primary	Number of patients with catheter related infection	any catheter related infection(exit site, lumen inection etc) will be recorded	6 months
Primary	Time of catheter occlusion or failure	catheteres occluded by thrombi will be documented	6 months
Primary	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	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
Secondary	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