Table 2.
Reportable adverse events
| Related to renal replacement therapy (RRT) | Related to central venous catheter (CVC) |
|---|---|
| RRT-associated hypotension: |
Hemorrhage at the site of CVC insertion: |
| Drop in blood pressure requiring one of: initiation of a vasopressor during RRT session, or need to escalate dose of a vasopressor during the RRT session, or premature discontinuation of RRT session, or any other intervention to stabilize blood pressure. |
Bleeding requiring transfusion of ≥1 unit(s) of packed red blood cells and/or surgical intervention/repair within 12 hours following insertion |
| Severe hypophosphatemia: |
CVC-associated bloodstream infection: |
| Serum phosphorus <0.5 mmol/L |
Bacteremia in 2 blood culture sets with no proven alternative source for bacteremia or culture-positive recovery of the same organism from the dialysis catheter upon removal |
| Severe hypokalemia: |
Ultrasonographically-confirmed thrombus attributed to CVC |
| Serum potassium <3.0 mmol/L | |
| Severe hypocalcemia: |
Pneumothorax (for catheters placed in the internal jugular or subclavian positions) |
| Albumin-adjusted serum calcium <2.00 mmol/L or ionized calcium <1.00 mmol/L | |
| Allergic reaction |
Hemothorax (for catheters placed in the internal jugular or subclavian positions) |
| Arrhythmia during dialysis: |
Air embolism |
| New atrial (excluding sinus tachycardia or sinus arrhythmia) or ventricular arrhythmia that develops during RRT and was not present prior to initiation of RRT |
|
| Seizure |
Inadvertent arterial puncture at time of CVC insertion |
| Hemorrhage in patient receiving RRT with heparin-based anticoagulation | Other CVC-related adverse events |
This table outlines the adverse events that are to be documented and reported during the first 14 days after randomization.