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

Zonguldak Ataturk State Hospital

Status: Completed

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

Treatments: Drug: Sodium bicarbonate; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT04772209

ZADH-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 441 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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441 participants in 2 patient groups

Sodium bicarbonate Arm

Active Comparator group

Description:

In this arm, the catheter lock solution is sodium bicarbonate

Treatment:

Drug: Sodium bicarbonate

Heparin arm

Active Comparator group

Description:

In this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution)

Treatment:

Drug: Heparin