Clinical trial NCT04054128: Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients
Official title: Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: End Stage Renal Disease
Vascular Access Complication
Catheter Complications
Hemodialysis Access Failure
Hemodialysis Catheter Infection
Keywords: Sodium bicarbonate lock
Heparin lock
Vascular access complication
Lead sponsor: Hospital General "Dr. Miguel Silva" de Morelia
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
name: NAUSLIFE HEMODIALYSIS CLINICS
First posted: 2019-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open label, clinical trial in chronic hemodialysis patients with a catheter as a vascular access, randomized to bicarbonate lock or heparin lock (control) as standard treatment.
Primary purpose: PREVENTION

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.

During each treatment, patients will be prescribed and monitored for complications and standard treatment will be provided to every patient. After each treatment, blood will be rinsed from dialysis lines with 0.9% saline solution back to the patient. Upon the conclusion of treatment, all catheters will be flushed with 10 mL 0.9% saline solution per blood line respectively, after saline flush, catheter lock will be prescribed; SBCL group with 7.5% sodium bicarbonate solution, at a dose of 2 milliliters per lumen, and HCL group with sodium heparin at a concentration of 1000 units per milliliter, at a dose of 2 milliliters per lumen. Catheter exit site dressing changes occurred after each HD treatment.

Niagra 13.5 French/20 cm non tunneled catheter will be the standard vascular access. All central venous catheters will be inserted by an expert operator under strict aseptic protocol. Catheter care will be performed by trained dialysis staff. At the end of dialysis, all catheters will be flushed and locked with the respectively arm solution.

Function assessment will be based on both, pressure and flow measurements on arterial line, as well as measurements of arterial and venous line pressures and flow during hemodialysis sessions. Infectious and thrombotic complications will be assessed as defined.

Eligibility criteria: 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

Primary outcomes:
measure: Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
timeFrame: 30 days.
measure: Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
timeFrame: 60 days
measure: Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
timeFrame: 90 days
Secondary outcomes:
measure: Incidence rate of catheter related bloodstream infection
timeFrame: 90 days
measure: Incidence rate of catheter thrombosis
timeFrame: 90 days
measure: Adverse events incidence
timeFrame: 90 days
Other outcomes:
Locations:
city: Morelia
country: Mexico
facility: Hospital General "Dr. Miguel Silva" de Morelia
state: Michoacan
Study officials:
affiliation: Hospital General "Dr. Miguel Silva" de Morelia
name: Israel Campos, M.D.
role: PRINCIPAL_INVESTIGATOR
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