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Completed

NCT Number: NCT02474810

Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Central venous catheters (CVCs) are used for vascular access by approximately 56% of our 380 hemodialysis (HD) patients at the Capital Health Renal Program. The major complication of these catheters includes thrombosis and infection. Catheter locking solutions such as recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and prevent clotting of the catheter during HD treatments and during the interdialytic period. Evidence to guide the use of rt-PA is limited. This quality assurance project will compare the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol for rt-PA in HD patients.

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Key information

Conditions

Chronic Renal Insufficiency Cardiovascular Diseases Chronic Disease Disease Attributes Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Thrombosis Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Health District Authority, Department of Medicine, Division of Nephrology

Halifax, Nova Scotia, b3h 2y9, Canada

About this study

The proposed study will be a retrospective cohort study of consecutive HD patients conducted at a HD unit using two catheter dysfunction protocols during January 2013 to Septebmer 2013. In the Intensive Protocol, rt-PA intervention is administered to all catheters based on blood flow and/or line reversal. In the Standard Protocol, rt-PA intervention is administered to all catheters based only on blood flow.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All adults undergoing HD with a tunneled CVC (both newly inserted CVCs as well as pre-existing CVCs) will be included.

Exclusion criteria

  • Patients were excluded from using the CVC dysfunction protocols if they had a known allergy or intolerance to rt-PA.
  • A physician order to proceed with the CVC dysfunction protocols was required if they met one of the following criteria:
  • CVC line insertion or exchange within 72 hours;
  • any surgery, organ biopsy, obstetrical delivery within 72 hours;
  • active bleeding; bleeding disorders; hemoglobin decrease greater than 20 g/L over 2 weeks;
  • active pericarditis; arterial puncture within 48 hours;
  • bacteremia with positive blood cultures.

Treatment and study plan

alteplase

Drug

Alteplase for CVC dysfunction.

Other names: Cathflo, rt-PA

Primary outcomes

  1. Alteplase use

    Time frame: 9 months

    Incident rate of rt-PA uses includes the numerator which will consist of the number of HD sessions during which a patient was administered rt-PA for catheter malfunction and the denominator will be the time period at risk in catheter days.

Secondary outcomes

  1. Rate of bacteremia

    Time frame: 9 months

    Rate of bacteremia will include the numberator which will consit of the number of definite or probable catheter related bacteremia events and the decominator will be the time period at risk in catheter days.

  2. Cost of alteplase

    Time frame: 9 months

    Cost of rt-PA will be calculated per TLD for the study period.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter Dysfunction Protocol Using Alteplase

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2015
Registry last updated
Aug 21, 2024

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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