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Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients

NCT04054128 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-04-30

No results posted yet for this study

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).

Conditions

  • End Stage Renal Disease
  • Vascular Access Complication
  • Catheter Complications
  • Hemodialysis Access Failure
  • Hemodialysis Catheter Infection

Interventions

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.

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.

Sponsors & Collaborators

  • Universidad Nacional Autonoma de Mexico

    collaborator OTHER

  • NAUSLIFE HEMODIALYSIS CLINICS

    collaborator UNKNOWN

  • Hospital General "Dr. Miguel Silva" de Morelia

    lead OTHER

Principal Investigators

  • Israel Campos, M.D. · Hospital General "Dr. Miguel Silva" de Morelia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2020-02-20
Completion
2020-09-28

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054128 on ClinicalTrials.gov