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

Not Applicable

Completed

• Conditions: Catheter Related Complication; Dialysis Catheter; Thrombosis; Catheter Infection; Catheter Dysfunction; Catheter Blockage; Catheter-Related Infections
• Interventions: Drug: Sodium bicarbonate; Drug: Heparin

• Registration Number: NCT04772209
• Lead Sponsor: Zonguldak Ataturk State Hospital

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-26
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium bicarbonate Arm	Sodium bicarbonate	In this arm, the catheter lock solution is sodium bicarbonate
Heparin arm	Heparin	In this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution)

Primary Outcome Measures

Name	Time	Method
Number of participants with catheter occlusion	6 months	The number of cases early catheter
Number of patients with catheter related infection	6 months	any catheter related infection(exit site, lumen inection etc) will be recorded
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
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.)
Time of catheter occlusion or failure	6 months	catheteres occluded by thrombi will be documented

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Cumhuriyet University Hospital; 🇹🇷 Sivas, TN, Turkey

Zonguldak ataturk state hospital; 🇹🇷 Zonguldak, TN, Turkey