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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-03-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Bicarbonate vs Heparin group (femoral vs jugular catheter)

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sodium bicarbonate Arm

In this arm, the catheter lock solution is sodium bicarbonate

Group Type ACTIVE_COMPARATOR

Sodium bicarbonate

Intervention Type DRUG

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 arm

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

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No