Study: NCT04011631

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: day 2 after complex cardiac surgery: stroke due to occlusion left middle cerebral artery. Extensive infacrction with cerebral herniation. No surgical treatment.

outcome: death
Frequency: 1 affected / 100 at risk

Adverse event: Acute Kidney Injury (AKI)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Prolonged ICU length of stay with AKI, low cardiac output syndrome and ventilator-associated pneumonia.

outcome: recovered
Frequency: 1 affected / 100 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: D0: CABG + Mitral Valve plasty (patient known with cardiomyopathy + reduced LV function)) D1: revision for acute massive bleeding D6: revision for bleeding: vasoplegia + cardiogenic shock, resistent to therapy outcome: death Study device not used
Frequency: 1 affected / 100 at risk

Adverse event: Multi Organ Failure (MOF)
Serious: yes
Organ System: General disorders
Notes: (D0 redo CABG + mitral valve replacement) Patient known with reduced LVEF and MI D1: Difficult weaning CPB due to LV failure and vasoplegia R/IABP In ICU deterioration of cardiogenic shock and MOF. outdome: death Study device not used
Frequency: 1 affected / 100 at risk

Adverse event: Atrial Fibbrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial fibrillation, not well tolerated, loss of cardiac output resuscitation (CPR) , reintubation and ventilation reurn of spontaneous circulation within 10 minutes outcome: resolved
Frequency: 1 affected / 100 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Notes: Difficult weaning post-op CABG/AVR. EEG revealed status epilepticus (patient known with epilepsy) outcome: ongoing
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 100 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ventilator-associated pneumonia
Frequency: 1 affected / 100 at risk

Adverse event: Elevated Troponin-T level
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 100 at risk

Adverse event: Low cardiac output syndrome
Serious: no
Organ System: Cardiac disorders
Notes: followed by ICU acquired weakness
Frequency: 1 affected / 100 at risk

Adverse event: Acute Kidney Injury - Failure
Serious: no
Organ System: Renal and urinary disorders
Notes: known chronic renal failure
Frequency: 1 affected / 100 at risk

Adverse event: Diplopia
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: pituitary adenoma
Frequency: 1 affected / 100 at risk

Adverse event: Trombopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Subdural haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Delirum
Serious: no
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Decreased kidney function
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Ischaemic stroke
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk