Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients (BICATH)

April 28, 2020 updated by: J ARMANDO VÁZQUEZ ÁVILA, MD, Hospital General "Dr. Miguel Silva" de Morelia
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Michoacan
      • Morelia, Michoacan, Mexico, 58020
        • Hospital General "Dr. Miguel Silva" de Morelia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Time Frame: 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.
30 days.
Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Time Frame: 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.
60 days
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.
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General "Dr. Miguel Silva" de Morelia

Collaborators

Universidad Nacional Autonoma de Mexico
NAUSLIFE HEMODIALYSIS CLINICS

Investigators

  • Principal Investigator: Israel Campos, M.D., Hospital General "Dr. Miguel Silva" de Morelia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 11, 2019

Primary Completion (ACTUAL)

February 20, 2020

Study Completion (ANTICIPATED)

September 28, 2020

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

August 9, 2019

First Posted (ACTUAL)

August 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 479/01/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on Sodium Bicarbonate 7.5% Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe