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NCT Number: NCT04772209

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

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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Key information

Conditions

Catheter Blockage Cardiovascular Diseases Catheter Dysfunction Catheter Infection Catheter Related Complication Catheter-Related Infections Dialysis Catheter; Thrombosis Embolism and Thrombosis Infections Thrombosis Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cumhuriyet University Hospital, Sivas, TN, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

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

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.

Primary outcomes

  1. Time to first catheter failure (day)

    Time frame: 6 months

    The time from first sucessful dialysis session to the last one (in days)

  2. Total Duration of catheter usage (day)

    Time frame: 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

  3. Number of participants with catheter occlusion

    Time frame: 6 months

    The number of cases early catheter

  4. Number of patients with catheter related infection

    Time frame: 6 months

    any catheter related infection(exit site, lumen inection etc) will be recorded

  5. Time of catheter occlusion or failure

    Time frame: 6 months

    catheteres occluded by thrombi will be documented

  6. Causes of premature catheter malfunction

    Time frame: 6 months

    any catheter needing exchange prematurly will be be evaluated for mulfunction cause (etiher mechanical thromus or kink rtc.)

Secondary outcomes

  1. Total number of dialysis sessions with active patent catheter usage

    Time frame: 6 months

    In some cases intensive treatment is indicated. the effect of frequent usage of catheteres will be evaluated

  2. Number of cases with venous thrombosis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zonguldak Ataturk State Hospital

Other

Collaborators

  • Cumhuriyet University
  • Sisli Hamidiye Etfal Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2021
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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