| Trial ID: | L1703 |
| Source ID: | NCT03627884
|
| Associated Drug: |
Sodium Bicarbonate Catheter Lock Solution
|
| Title: |
Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Acute Renal Failure|Hemodialysis Catheter Infection|Hemodialysis Complication|Hemodialysis Access Failure|Hemodialysis Catheter-Associated Bacteremia
|
| Interventions: |
DRUG: Sodium Bicarbonate Catheter Lock Solution|DRUG: Normal Saline Catheter Lock Solution
|
| Outcome Measures: |
Primary: Lumen Clot Formation, Catheter Loss Due to Lumen Clot Formation, Approximately 18 months|Catheter Related Infection, Catheter Loss Due to Catheter Related Infection, Approximately 18 months|Malfunction, Catheter Loss Due to Malfunction, Approximately 18 months|Overall Cause, Catheter Loss Due to All Causes, Approximately 18 months | Secondary: Death, Number of deaths reported during the study period, Approximately 18 months|Arrhythmia, Incidence of significant arrhythmia during dialysis requiring urgent intervention, Approximately 18 months|Hemodynamic Instability, Incidence of extreme hypotension or hypertension requiring urgent intervention, Approximately 18 months
|
| Sponsor/Collaborators: |
Sponsor: Coney Island Hospital, Brooklyn, NY
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
451
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2016-10-01
|
| Completion Date: |
2018-03-30
|
| Results First Posted: |
|
| Last Update Posted: |
2018-08-14
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT03627884
|
