Study: NCT02790788

Adverse event: Second Cardiac Arrest
Serious: yes
Organ System: General disorders
Notes: Second, fatal Cardiac Arrest of various etiologies during follow-up
Frequency: 44 affected / 46 at risk

Adverse event: Cardiac arrest associated multiple organ failure
Serious: yes
Organ System: General disorders
Notes: Cardiac arrest associated multiple organ failure causing second cardiac arrest within 72 hours after randomization
Frequency: 19 affected / 46 at risk

Adverse event: Acute Kidney Injury / Renal Failure
Serious: yes
Organ System: General disorders
Notes: Acute deterioration in Renal function resulting in a corresponding Sequentiial Organ Dysfunction Assessment sub-score of 3 or more, and/or anuria, and/or need for renal replacement therapy
Frequency: 7 affected / 46 at risk

Adverse event: Severe Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Drop of platelet count to less than 50000 per microiter
Frequency: 6 affected / 46 at risk

Adverse event: Sepsis / Septic Shock
Serious: yes
Organ System: Infections and infestations
Notes: Bacteremia during follow-up, and associated with a systemic inflammatory response, with/without new organ failure(s), with/without need for vasopressors to maintain a mean arterial pressure of 70 mmHg, and with/without lactate exceeding 2.0 mmol/L
Frequency: 18 affected / 46 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: New infiltrate in chest x-ray, associated with 1) a systemic inflammatory response, and 2) microbiological evidence from blood and/or bronchial secretions and/or bronchoalveolar lavage
Frequency: 11 affected / 46 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PaO2/FiO2 \< 300 mmHg, while ventilated at PEEP of \>= 5 cmH2O, bilateral chest x-ray infiltrates, no evidence of cardiogenic pulmonary edema, and patient exposure to a precipitating factor (e.g. aspiration, trauma, etc.) within the last 7 days.
Frequency: 4 affected / 46 at risk

Adverse event: Postresuscitation heart failure
Serious: yes
Organ System: General disorders
Notes: Postresuscitation cardiac index of less than 2.0 L/min/m2 Body Surface Area requiring inotropic support
Frequency: 2 affected / 46 at risk

Adverse event: New life-threatening arrhythmia
Serious: yes
Organ System: General disorders
Notes: New supraventricular or ventricular arrhythmia requiring immediate management according to current Resuscitaiton Guidelines
Frequency: 2 affected / 46 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: General disorders
Notes: New laboratory and electrocardiographic evidence of myocardial ischemia leading to regional dysfunction of the myocardium (e.g. new akinesis/hypokinesis in ultrasound) and requiring a therapeutic intervention.
Frequency: 1 affected / 46 at risk

Adverse event: Paresis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Limb and/or respiratory muscle weakness in the context of critical illness associated polyneuropathy / myopathy
Frequency: 3 affected / 46 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: One case of tension pneumothorax, or status asthmaticus, or gastrointestinal bleeding +/- hemorrhagic shock, or superior vena cava thrombosis, or pancytopenia, or brain edema, or stage IV pressure ulcer, or acute limb ischemia, or pancreatitis.
Frequency: 5 affected / 46 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Notes: Number of patients with at least one episode of blood glucose exceeding 200 mg/dL
Frequency: 23 affected / 46 at risk

Adverse event: Second Cardiac Arrest
Serious: yes
Organ System: General disorders
Notes: Second, fatal Cardiac Arrest of various etiologies during follow-up
Frequency: 49 affected / 54 at risk

Adverse event: Cardiac arrest associated multiple organ failure
Serious: yes
Organ System: General disorders
Notes: Cardiac arrest associated multiple organ failure causing second cardiac arrest within 72 hours after randomization
Frequency: 20 affected / 54 at risk

Adverse event: Acute Kidney Injury / Renal Failure
Serious: yes
Organ System: General disorders
Notes: Acute deterioration in Renal function resulting in a corresponding Sequentiial Organ Dysfunction Assessment sub-score of 3 or more, and/or anuria, and/or need for renal replacement therapy
Frequency: 10 affected / 54 at risk

Adverse event: Severe Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Drop of platelet count to less than 50000 per microiter
Frequency: 5 affected / 54 at risk

Adverse event: Sepsis / Septic Shock
Serious: yes
Organ System: Infections and infestations
Notes: Bacteremia during follow-up, and associated with a systemic inflammatory response, with/without new organ failure(s), with/without need for vasopressors to maintain a mean arterial pressure of 70 mmHg, and with/without lactate exceeding 2.0 mmol/L
Frequency: 17 affected / 54 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: New infiltrate in chest x-ray, associated with 1) a systemic inflammatory response, and 2) microbiological evidence from blood and/or bronchial secretions and/or bronchoalveolar lavage
Frequency: 9 affected / 54 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PaO2/FiO2 \< 300 mmHg, while ventilated at PEEP of \>= 5 cmH2O, bilateral chest x-ray infiltrates, no evidence of cardiogenic pulmonary edema, and patient exposure to a precipitating factor (e.g. aspiration, trauma, etc.) within the last 7 days.
Frequency: 2 affected / 54 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Microbiologically proven infection of the upper urinary tract, associated with a systemic inflammatory response, and/or bacteremia.
Frequency: 2 affected / 54 at risk

Adverse event: New life-threatening arrhythmia
Serious: yes
Organ System: General disorders
Notes: New supraventricular or ventricular arrhythmia requiring immediate management according to current Resuscitaiton Guidelines
Frequency: 3 affected / 54 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Gastrointestinal disorders
Notes: New worsening of liver function associated with a corresponding Sequential Organ Failure Assessment sub-score of 3 or more.
Frequency: 3 affected / 54 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: General disorders
Notes: New laboratory and electrocardiographic evidence of myocardial ischemia leading to regional dysfunction of the myocardium (e.g. new akinesis/hypokinesis in ultrasound) and requiring a therapeutic intervention.
Frequency: 2 affected / 54 at risk

Adverse event: Paresis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Limb and/or respiratory muscle weakness in the context of critical illness associated polyneuropathy / myopathy
Frequency: 2 affected / 54 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: One case of tension pneumothorax, or status asthmaticus, or gastrointestinal bleeding +/- hemorrhagic shock, or superior vena cava thrombosis, or pancytopenia, or brain edema, or stage IV pressure ulcer, or acute limb ischemia, or pancreatitis.
Frequency: 6 affected / 54 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Notes: Number of patients with at least one episode of blood glucose exceeding 200 mg/dL
Frequency: 33 affected / 54 at risk