Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Study Overview
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 (experimental group) and heparin lock group (control group). Catheter pressures, flow, patency and infection outcomes will be compare between groups at different time points (30, 60 and 90 days).
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 study is to evaluate the efficacy of catheter lock with bicarbonate vs heparin in chronic hemodialysis patients. Primary outcome will be catheter function. Secondary outcomes will be Infectious complications, thrombotic complications, and frequency of adverse effects between groups.
All patients provided written informed consent before enrollment. The trial protocol was approved by Hospital General "Dr. Miguel Silva" Internal Review Board, register number 17-CI-16053153, and Research & Ethics committee, with register number 16-CEI-004-20161212, Study registry # 479/01/9.
Patients between 18-65 years old, incident or prevalent chronic hemodialysis, with 1 month of clinical stability and with temporal catheter as vascular access for hemodialysis are eligible. A total of 60 patients will be included in the study. All patients will be randomly assigned into one of two groups: SBCL (n=30), intervention group and HCL (n=30), as control group.
Before each hemodialysis treatment, catheters and connections will be inspected for leaks, evidence of damage, exit-site infection and tunnel infection. Intraluminal SBCL or HCL solution will be removed before connecting the hemodialysis catheter to a dialysis machine prior to any treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Sodium bicarbonate catheter lock group (SBCL)
Chronic hemodialysis patients with a catheter as a vascular access, will be lock with sodium bicarbonate 7.5% Injection.
Intervention: Sodium Bicarbonate 7.5% Injection (Drug)
Heparin catheter lock group (HCL)
Chronic hemodialysis patients with a catheter as a vascular access, will be lock with heparin, 1000 Units/mL injectable solution
Intervention: Heparin Sodium, 1000 Units/mL Injectable Solution 1 (Drug)
Outcomes
Primary Outcomes
Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Time Frame: 90 days
Arterial line pressure\[mmHg\] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.
Secondary Outcomes
- Incidence rate of catheter related bloodstream infection(90 days)
- Incidence rate of catheter thrombosis(90 days)
- Adverse events incidence(90 days)
Investigators
J ARMANDO VÁZQUEZ ÁVILA, MD
Nephrology fellow
Hospital General "Dr. Miguel Silva" de Morelia