BICATH: Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients

Sponsor

Hospital General "Dr. Miguel Silva" de Morelia (Other)

Overall Status

Unknown status

CT.gov ID

NCT04054128

Collaborator

Universidad Nacional Autonoma de Mexico (Other), NAUSLIFE HEMODIALYSIS CLINICS (Other)

Enrollment

Location

Arms

12.6

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease Vascular Access Complication Catheter Complications Hemodialysis Access Failure Hemodialysis Catheter Infection	Drug: Sodium Bicarbonate 7.5% Injection Drug: Heparin Sodium, 1000 Units/mL Injectable Solution 1	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients

Actual Study Start Date :

Sep 11, 2019

Actual Primary Completion Date :

Feb 20, 2020

Anticipated Study Completion Date :

Sep 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Sodium Bicarbonate 7.5% Injection Sodium bicarbonate solution for catheter lock; 7.5% sodium bicarbonate solution will be used for catheter lock in both catheter lumens, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months. Other Names: Bicarnat® arm
Active Comparator: 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	Drug: Heparin Sodium, 1000 Units/mL Injectable Solution 1 Heparin for catheter lock: 1000 u/mL heparin solution will be used for catheter lock in both catheter lumens as standard treatment, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months. Other Names: Inhepar® arm

Arm

Intervention/Treatment

Experimental: 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.

Drug: Sodium Bicarbonate 7.5% Injection

Sodium bicarbonate solution for catheter lock; 7.5% sodium bicarbonate solution will be used for catheter lock in both catheter lumens, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.

Other Names:

Bicarnat® arm

Active Comparator: 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

Drug: Heparin Sodium, 1000 Units/mL Injectable Solution 1

Heparin for catheter lock: 1000 u/mL heparin solution will be used for catheter lock in both catheter lumens as standard treatment, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.

Other Names:

Inhepar® arm

Outcome Measures

Primary Outcome Measures

Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients [30 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.
Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients [60 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.
Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients [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 Outcome Measures

Incidence rate of catheter related bloodstream infection [90 days]
Catheter related bloodstream infection rate (events per 100 days/catheter) will be compare between sodium bicarbonate lock versus heparin lock in chronic hemodialysis patients
Incidence rate of catheter thrombosis [90 days]
Catheter thrombosis rate (events per 100 days/catheter) will be compare between sodium bicarbonate lock versus heparin lock in chronic hemodialysis patients
Adverse events incidence [90 days]
To compare the frequency of hemorrhagic event, anaphylaxis, hypernatremia or death between sodium bicarbonate lock vs heparin lock in chronic hemodialysis patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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