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Completed

NCT Number: NCT00571259

Prophylactic Antimicrobial Catheter Lock

This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Satellite Healthcare, Inc

Mountain View, California, 94041, United States

About this study

The study is a randomized, double blinded, prospective, multicenter, clinical trial. All patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group will be less than the heparin arm.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.
  • Must be at least 18 years old
  • Compliant with a dialysis treatment schedule
  • Plans to continue hemodialysis treatment and follow-up at the investigational site
  • Must be able to care for the exit site independently or have someone who is able to care for the site for them
  • Must be able to sign the informed consent document

Exclusion criteria

  • The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred
  • Active exit site or tunnel infection
  • Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening
  • Known to have antibodies to heparin
  • Allergy to pork heparin
  • Allergy to gentamicin
  • Subject is pregnant
  • Known intravenous drug abuse

Treatment and study plan

Heparin 1000U/mL

Drug

A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis

4% Sodium Citrate with Gentamicin 320 mcg/mL

Drug

A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis

Primary outcomes

  1. Rate of Device-related Bacteremia

    Time frame: 5 years

    Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection

Secondary outcomes

  1. Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow

    Time frame: 5 years

    The rate of thrombolytic agent use required to maintain blood flow adequate for dialysis was used as an objective measure of clinically significant catheter clotting.

Sponsors and collaborators

Lead sponsor

Satellite Healthcare

Other

Registry information

Official study title

Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial

Acronym: ALLOCK

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2007
Registry last updated
Sep 22, 2021

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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