Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Endothelial function |
Percent change in flow mediated dilation of the brachial artery after cardiac surgery |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Acute kidney injury |
Acute kidney injury by the KDIGO criteria |
From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days |
|
| Secondary |
Renal blood flow velocity |
Renal blood flow velocity measured by pulse wave doppler |
Intra-operative time point: after cardiopulmonary bypass, up to 12 hours |
|
| Secondary |
Acute kidney injury risk |
Acute kidney injury risk measured by urinary TIMP2*IGFBP7 |
Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours |
|
| Secondary |
Perioperative death |
Death after surgery during the surgical hospital encounter |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Myocardial infarction |
Myocardial infarction after surgery |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Stroke |
Stroke after surgery |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
New renal failure requiring renal replacement therapy |
New renal failure requiring renal replacement therapy after surgery |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Re-exploration for bleeding |
Need for surgical re-exploration to control hemorrhage |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Post-operative sepsis |
Post-operative sepsis determined by positive blood culture |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
New onset atrial fibrillation |
Post-operative new onset atrial fibrillation |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Post-operative blood loss |
Post-operative blood loss determined by total surgical drain output |
From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours |
|
| Secondary |
Duration of mechanical ventilation |
Duration of mechanical ventilation after surgery |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Post-operative delirium |
Post-operative delirium determined by the Confusion Assessment Method for the Intensive Care Unit score |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Post-operative hospital length of stay |
Duration of hospital stay after surgery |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
New requirement for mechanical circulatory support |
Post-operative initiation of mechanical circulatory support |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Intra-operative red blood cell transfusion |
Intra-operative red blood cell transfusion in units |
During the intra-operative time period, up to 12 hours |
|
| Secondary |
Post-operative red blood cell transfusion |
Post-operative red blood cell transfusion in units |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Post-operative platelet transfusion |
Post-operative platelet transfusion in units |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Post-operative plasma transfusion |
Post-operative plasma transfusion in units |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Post-operative cryoprecipitate transfusion |
Post-operative cryoprecipitate transfusion in units |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
Intra-operative platelet transfusion |
Intra-operative platelet transfusion in units |
During the intra-operative time period, up to 12 hours |
|
| Secondary |
Intra-operative plasma transfusion |
Intra-operative plasma transfusion in units |
During the intra-operative time period, up to 12 hours |
|
| Secondary |
Intra-operative cryoprecipitate transfusion |
Intra-operative cryoprecipitate transfusion in units |
During the intra-operative time period, up to 12 hours |
|
| Secondary |
Glycocalyx thickness |
Glycocalyx thickness determined by sublingual microcirculation microscopy |
Start of the intra-operative period to 24 hours after intensive care unit admission |
|
| Secondary |
Microvascular circulatory function |
Microvascular circulatory function determined by sublingual microcirculation microscopy |
Start of the intra-operative period to 24 hours after intensive care unit admission |
|
| Secondary |
New onset of acute lung injury |
Diagnosis of acute lung injury by PaO2 to FiO2 ratio |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
New onset of left ventricular diastolic dysfunction |
Diagnosis new onset diastolic dysfunction by annular e' velocity: septal e' < 7 cm/sec, lateral e' <10 cm/sec, average E/e' ratio > 14, LA volume index > 34 mL/m2, and peak TR velocity > 2.8 m/sec. |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
New onset of left ventricular systolic dysfunction |
New onset of left ventricular systolic dysfunction determined by a LV ejection fraction <50% |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
| Secondary |
New onset of right ventricular systolic dysfunction |
New onset of right ventricular systolic dysfunction determined by a tricuspid annular plane systolic excursion less than 16 mm |
From intensive care unit admission after surgery to hospital discharge, up to 30 days |
|
