Status:
UNKNOWN
Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients
Lead Sponsor:
Hospital General "Dr. Miguel Silva" de Morelia
Collaborating Sponsors:
Universidad Nacional Autonoma de Mexico
NAUSLIFE HEMODIALYSIS CLINICS
Conditions:
End Stage Renal Disease
Vascular Access Complication
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Prospective clinical trial to evaluate the efficacy of catheter lock with bicarbonate vs heparin in chronic hemodialysis patients. Two groups will be created, sodium bicarbonate lock group (experiment...
Detailed Description
A prospective, randomized, clinical, open-label trial at Hospital General "Dr. Miguel Silva" de Morelia, Mexico. The study period will be between august 16, 2019 to November 16, 2019. The aim of this...
Eligibility Criteria
Inclusion
- Patients who accept participation and sign informed consent.
- Incident or prevalent chronic hemodialysis patients who receive at least 2 sessions per week with 1 month of clinical stability defined as: no hospitalizations, no vascular access infections, no changes in blood flow prescription due to vascular access dysfunction.
- Patients with temporal catheter (Niagra 13.5 French/20 cm length, BARD Access System, Salt Lake City, Utah, USA) as vascular access for hemodialysis.
Exclusion
- Catheter dysfunction at baseline
- On anticoagulation therapy
- Patients with known coagulopathy or hemophilia
- Patients with Child-Pugh B or C liver failure
- Patients with thrombocytopenia less than 100,000 u / L
- Patients with central vessel stenosis and vena cava syndrome, previously documented.
- Patients with vascular access exhaustion.
- Patients who have undergone more than 2 vascular approaches for hemodialysis catheters.
- Patients with heparin-induced thrombocytopenia
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04054128
Start Date
September 11 2019
End Date
September 28 2020
Last Update
April 30 2020
Active Locations (1)
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1
Hospital General "Dr. Miguel Silva" de Morelia
Morelia, Michoacán, Mexico, 58020