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Table 2 Reportable adverse events

From: Standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI): study protocol for a randomized controlled trial

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
  1. This table outlines the adverse events that are to be documented and reported during the first 14 days after randomization.