Trial Outcomes & Findings for Acute Renal Failure Trial Network (ATN) Study (NCT NCT00076219)
NCT ID: NCT00076219
Last Updated: 2013-08-23
Results Overview
60-day all-cause mortality
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1124 participants
Primary outcome timeframe
60 days
Results posted on
2013-08-23
Participant Flow
Participant milestones
| Measure |
Intensive Renal Replacement Therapy
In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
|
Less-intensive Renal Replacement Therapy
In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
|
|---|---|---|
|
Overall Study
STARTED
|
563
|
561
|
|
Overall Study
COMPLETED
|
545
|
550
|
|
Overall Study
NOT COMPLETED
|
18
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Renal Failure Trial Network (ATN) Study
Baseline characteristics by cohort
| Measure |
Intensive Renal Replacement Therapy
n=563 Participants
In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
|
Less-intensive Renal Replacement Therapy
n=561 Participants
In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
|
Total
n=1124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
341 Participants
n=113 Participants
|
335 Participants
n=163 Participants
|
676 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
222 Participants
n=113 Participants
|
226 Participants
n=163 Participants
|
448 Participants
n=160 Participants
|
|
Age Continuous
|
59.6 years
STANDARD_DEVIATION 15.3 • n=113 Participants
|
59.7 years
STANDARD_DEVIATION 15.2 • n=163 Participants
|
59.7 years
STANDARD_DEVIATION 15.3 • n=160 Participants
|
|
Gender
Female
|
154 participants
n=113 Participants
|
176 participants
n=163 Participants
|
330 participants
n=160 Participants
|
|
Gender
Male
|
409 participants
n=113 Participants
|
384 participants
n=163 Participants
|
793 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Number of all-cause mortality by day 60
60-day all-cause mortality
Outcome measures
| Measure |
Intensive Renal Replacement Therapy
n=563 Participants
In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
|
Less-intensive Renal Replacement Therapy
n=561 Participants
In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
|
|---|---|---|
|
60-day All-cause Mortality
|
302 participants
|
289 participants
|
Adverse Events
Intensive Renal Replacement Therapy
Serious events: 287 serious events
Other events: 0 other events
Deaths: 0 deaths
Less-intensive Renal Replacement Therapy
Serious events: 280 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intensive Renal Replacement Therapy
n=563 participants at risk
In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
|
Less-intensive Renal Replacement Therapy
n=561 participants at risk
In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
|
|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
8/563 • Number of events 9
|
1.6%
9/561 • Number of events 9
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Cardiac disorders
Atrial thrombosis
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Bradycardia
|
0.36%
2/563 • Number of events 2
|
0.36%
2/561 • Number of events 2
|
|
Cardiac disorders
Cardiac aneurysm
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.36%
2/563 • Number of events 2
|
0.36%
2/561 • Number of events 2
|
|
Cardiac disorders
Cardiac failure
|
0.36%
2/563 • Number of events 2
|
0.36%
2/561 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.36%
2/563 • Number of events 2
|
0.89%
5/561 • Number of events 5
|
|
Cardiac disorders
Cardiogenic shock
|
0.53%
3/563 • Number of events 3
|
0.18%
1/561 • Number of events 1
|
|
Cardiac disorders
Cardiomegaly
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Electromechanical dissociation
|
0.36%
2/563 • Number of events 2
|
0.00%
0/561
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Cardiac disorders
Mitral valve disease
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
2/563 • Number of events 2
|
1.6%
9/561 • Number of events 9
|
|
Cardiac disorders
Pericardial rub
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Cardiac disorders
Rhythm idioventricular
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Sinus bradycardia
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Tachycardia
|
0.36%
2/563 • Number of events 2
|
0.00%
0/561
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Ventricular failure
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Cardiac disorders
Ventricular fibrillation
|
0.18%
1/563 • Number of events 1
|
0.36%
2/561 • Number of events 2
|
|
Cardiac disorders
Ventricular tachycardia
|
0.53%
3/563 • Number of events 3
|
1.1%
6/561 • Number of events 8
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.53%
3/563 • Number of events 4
|
0.53%
3/561 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.2%
7/563 • Number of events 7
|
0.18%
1/561 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.36%
2/563 • Number of events 2
|
0.00%
0/561
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/563
|
0.36%
2/561 • Number of events 2
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
General disorders
Adverse drug reaction
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
General disorders
Catheter site haemorrhage
|
0.53%
3/563 • Number of events 3
|
0.71%
4/561 • Number of events 4
|
|
General disorders
Chest pain
|
0.00%
0/563
|
0.36%
2/561 • Number of events 3
|
|
General disorders
Death
|
1.1%
6/563 • Number of events 6
|
0.36%
2/561 • Number of events 2
|
|
General disorders
Multi-organ failure
|
7.1%
40/563 • Number of events 40
|
8.2%
46/561 • Number of events 48
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
1.6%
9/563 • Number of events 9
|
0.89%
5/561 • Number of events 5
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Hepatobiliary disorders
Liver disorder
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
Immune system disorders
Graft versus host disease
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
Immune system disorders
Heart transplant rejection
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Immune system disorders
Lung transplant rejection
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Bacteraemia
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Bacterial sepsis
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Catheter related infection
|
0.53%
3/563 • Number of events 3
|
0.36%
2/561 • Number of events 2
|
|
Infections and infestations
Catheter site infection
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Empyema
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Endocarditis
|
0.53%
3/563 • Number of events 3
|
0.18%
1/561 • Number of events 1
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Infections and infestations
Fungaemia
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Infections and infestations
Fungal infection
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Fungal sepsis
|
0.36%
2/563 • Number of events 2
|
0.36%
2/561 • Number of events 2
|
|
Infections and infestations
Hepatitis C
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Klebsiella sepsis
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Lung infection pseudomonal
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
Infections and infestations
Pneumococcal sepsis
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Pneumonia
|
0.53%
3/563 • Number of events 3
|
0.53%
3/561 • Number of events 3
|
|
Infections and infestations
Pneumonia adenoviral
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Infections and infestations
Sepsis
|
5.7%
32/563 • Number of events 34
|
5.9%
33/561 • Number of events 35
|
|
Infections and infestations
Sepsis syndrome
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Infections and infestations
Septic shock
|
3.9%
22/563 • Number of events 22
|
5.5%
31/561 • Number of events 33
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.36%
2/563 • Number of events 2
|
0.00%
0/561
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Complications of bone marrow transplant
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.36%
2/563 • Number of events 2
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Haemodialysis-induced symptom
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Haemothorax
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.89%
5/563 • Number of events 5
|
0.36%
2/561 • Number of events 2
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Non-accidental overdose
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Injury, poisoning and procedural complications
Overdose
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.53%
3/563 • Number of events 3
|
0.00%
0/561
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.71%
4/563 • Number of events 4
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Investigations
Haematocrit decreased
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Investigations
Oxygen saturation decreased
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Metabolism and nutrition disorders
Acidosis
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.71%
4/563 • Number of events 4
|
0.18%
1/561 • Number of events 1
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/563
|
0.89%
5/561 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.36%
2/563 • Number of events 2
|
0.18%
1/561 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma
|
0.00%
0/563
|
0.36%
2/561 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.36%
2/563 • Number of events 2
|
0.18%
1/561 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.36%
2/563 • Number of events 2
|
0.00%
0/561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.18%
1/563 • Number of events 1
|
0.36%
2/561 • Number of events 2
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
2/563 • Number of events 2
|
0.18%
1/561 • Number of events 1
|
|
Nervous system disorders
Coma
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.36%
2/563 • Number of events 2
|
0.53%
3/561 • Number of events 3
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.71%
4/563 • Number of events 4
|
0.36%
2/561 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.36%
2/563 • Number of events 2
|
0.00%
0/561
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.36%
2/563 • Number of events 2
|
0.00%
0/561
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.36%
2/563 • Number of events 2
|
0.00%
0/561
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.36%
2/563 • Number of events 2
|
0.53%
3/561 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.36%
2/563 • Number of events 2
|
0.89%
5/561 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal disorder
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Surgical and medical procedures
Abscess drainage
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/563
|
0.36%
2/561 • Number of events 2
|
|
Surgical and medical procedures
Cardiac operation
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Surgical and medical procedures
Colectomy
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Surgical and medical procedures
Coronary artery surgery
|
0.36%
2/563 • Number of events 2
|
0.00%
0/561
|
|
Surgical and medical procedures
Thoracotomy
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Surgical and medical procedures
Ventricular septal defect repair
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Vascular disorders
Air embolism
|
0.18%
1/563 • Number of events 2
|
0.18%
1/561 • Number of events 1
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.18%
1/563 • Number of events 1
|
0.36%
2/561 • Number of events 2
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/563
|
0.53%
3/561 • Number of events 3
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Vascular disorders
Haemodynamic instability
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Vascular disorders
Haemorrhage
|
0.18%
1/563 • Number of events 1
|
0.18%
1/561 • Number of events 1
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Vascular disorders
Hypotension
|
10.3%
58/563 • Number of events 82
|
8.9%
50/561 • Number of events 78
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/563
|
0.18%
1/561 • Number of events 1
|
|
Vascular disorders
Peripheral ischaemia
|
0.18%
1/563 • Number of events 1
|
0.00%
0/561
|
|
Vascular disorders
Shock
|
0.53%
3/563 • Number of events 3
|
0.00%
0/561
|
Other adverse events
Adverse event data not reported
Additional Information
Paul M. Palevsky MD
VA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh, PA
Phone: 410-360-3932
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place