| Trial ID: | L1549 |
| Source ID: | NCT04054128
|
| Associated Drug: |
Sodium Bicarbonate 7.5% Injection
|
| Title: |
Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients
|
| Acronym: |
BICATH
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Vascular Access Complication|Catheter Complications|Hemodialysis Access Failure|Hemodialysis Catheter Infection
|
| Interventions: |
DRUG: Sodium Bicarbonate 7.5% Injection|DRUG: Heparin Sodium, 1000 Units/mL Injectable Solution 1
|
| Outcome Measures: |
Primary: Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients, 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, 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, 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: Incidence rate of catheter related bloodstream infection, 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, 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, To compare the frequency of hemorrhagic event, anaphylaxis, hypernatremia or death between sodium bicarbonate lock vs heparin lock in chronic hemodialysis patients, 90 days
|
| Sponsor/Collaborators: |
Sponsor: Hospital General "Dr. Miguel Silva" de Morelia | Collaborators: Universidad Nacional Autonoma de Mexico|NAUSLIFE HEMODIALYSIS CLINICS
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2019-09-11
|
| Completion Date: |
2020-09-28
|
| Results First Posted: |
|
| Last Update Posted: |
2020-04-30
|
| Locations: |
Hospital General "Dr. Miguel Silva" de Morelia, Morelia, Michoacan, 58020, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT04054128
|
