Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

NCT02474810 | Completed

• 1 other identifier: Dialysis Catheter Protcols
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Renal Insufficiency

Keywords

central venous catheters; hemodialysis; thrombosis; tissue plasminogen activator

Outcome Measures

Primary Outcomes (1)

• Alteplase use

  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.

  9 months

Secondary Outcomes (2)

• Rate of bacteremia

  9 months

• Cost of alteplase

  9 months

Study Arms (2)

Intensive

EXPERIMENTAL

In the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal

Drug: Alteplase

Standard

EXPERIMENTAL

In the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow.

Drug: Alteplase

Interventions

Alteplase DRUG

Alteplase for CVC dysfunction.

Also known as: Cathflo, rt-PA

Intensive; Standard

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

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

Halifax, Nova Scotia, b3h 2y9, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Thrombosis

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Jo-Anne S Wilson, PharmD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 18, 2015
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CA (1)