Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02651428 | Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection | PHASE3 | COMPLETED | 806 | — | — | Dec 1, 2015 | Oct 1, 2018 | Feb 25, 2025 | 5 | United States |
CRBSI was defined as the same organism grown from at least one positive blood culture from a peripheral site or bloodline sample, or either the arterial or venous catheter hub. The final assessment of CRBSI was determined by a Clinical Adjudication Committee (CAC) who used both clinical documentation and blood culture results in their assessment.
| Arm | Type | Description |
|---|---|---|
| Neutrolin arm | EXPERIMENTAL | Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution |
| Heparin arm | ACTIVE_COMPARATOR | Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution |
| Name | Type | Description |
|---|---|---|
| Neutrolin | DRUG | Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session |
| Heparin | DRUG | Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session |
Inclusion Criteria: 1. Subject has ESRD and undergoes chronic HD at least two times per week 2. Subject has a HD catheter that has demonstrated the ability to achieve a minimum blood flow of at least 250 mL/min for at least two consecutive dialysis sessions blood flow to enable successful HD 3. The...