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Standard for Chronic Kidney Disease

N/A
Waitlist Available
Led By Jo-Anne S Wilson, PharmD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All adults undergoing HD with a tunneled CVC (both newly inserted CVCs as well as pre-existing CVCs) will be included.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study 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.

Eligible Conditions
  • Chronic Kidney Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alteplase use
Secondary outcome measures
Cost of alteplase
Rate of bacteremia

Side effects data

From 2017 Phase 4 trial • 81 Patients • NCT02159521
10%
Deep vein thrombosis
8%
Nausea
6%
Procedural haemorrhage
4%
Pain in extremity
4%
Back pain
3%
Bradycardia
3%
Asthma
3%
Haematoma
3%
Anaemia
3%
Haematuria
3%
Pruritus
3%
Contusion
3%
Anxiety
1%
Upper gastrointestinal haemorrhage
1%
Dyspnoea
1%
Pulmonary embolism
1%
Osteomyelitis
1%
Urinary tract infection
1%
Epistaxis
1%
Joint effusion
1%
Abdominal pain
1%
Dizziness
1%
Uterine haemorrhage
1%
Post procedural haemorrhage
1%
Oedema
1%
Groin pain
1%
Skin ulcer
1%
Migraine
1%
Blood fibrinogen decreased
1%
Cardiac failure congestive
1%
Venous occlusion
1%
Heparin-induced thrombocytopenia
1%
Atrial fibrillation
1%
Septic shock
1%
Oxygen saturation decreased
1%
Rash
1%
Haemoptysis
1%
Constipation
1%
Sinusitis
1%
Haemorrhage
1%
Dysuria
1%
Hypoaesthesia
1%
Insomnia
1%
Drug hypersensitivity
1%
Squamous cell carcinoma
1%
Hypertension
1%
Pneumonia aspiration
1%
Lactic acidosis
1%
Ecchymosis
1%
Injection site haemorrhage
1%
Pelvic venous thrombosis
1%
Ventricular extrasystoles
100%
80%
60%
40%
20%
0%
Study treatment Arm
EkoSonic® Endovascular System

Trial Design

2Treatment groups
Experimental Treatment
Group I: StandardExperimental Treatment1 Intervention
In the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow.
Group II: IntensiveExperimental Treatment1 Intervention
In the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alteplase
FDA approved

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor
259 Previous Clinical Trials
83,843 Total Patients Enrolled
Jo-Anne S Wilson, PharmDPrincipal InvestigatorNova Scotia Health Authority

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol
Jo-Anne Wilson 2013. "Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02474810.
All > Dialysis
~3 spots leftby May 2025
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