End Stage Renal Disease Clinical Trial
Official title:
Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation
Verified date | August 2018 |
Source | Coney Island Hospital, Brooklyn, NY |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, randomized, comparative clinical and open-label trial comparing sodium bicarbonate catheter lock solution (SBCLS) to normal saline catheter lock solution (NSCLS) use in HD patients with central venous catheters (CVC).
Status | Completed |
Enrollment | 451 |
Est. completion date | March 30, 2018 |
Est. primary completion date | March 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients presenting over the age of 18 requiring hemodialysis via CVCs were eligible. Exclusion Criteria: - Having a poor venous system with inadequate blood flow for appropriate HD. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Coney Island Hospital, Brooklyn, NY |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lumen Clot Formation | Catheter Loss Due to Lumen Clot Formation | Approximately 18 months | |
Primary | Catheter Related Infection | Catheter Loss Due to Catheter Related Infection | Approximately 18 months | |
Primary | Malfunction | Catheter Loss Due to Malfunction | Approximately 18 months | |
Primary | Overall Cause | Catheter Loss Due to All Causes | Approximately 18 months | |
Secondary | Death | Number of deaths reported during the study period | Approximately 18 months | |
Secondary | Arrhythmia | Incidence of significant arrhythmia during dialysis requiring urgent intervention | Approximately 18 months | |
Secondary | Hemodynamic Instability | Incidence of extreme hypotension or hypertension requiring urgent intervention | Approximately 18 months |
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