Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) fo... | NCT01046669

Label	Type	Description	Intervention Names
Control	Sham Comparator	Standard medical care for septic shock	Other: Standard medical care for septic shock
Treatment	Experimental	Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock	Device: TORAYMYXIN PMX-20R (PMX cartridge) Other: Standard medical care for septic shock

Name	Type	Description	Arm Group Labels	Other Names
TORAYMYXIN PMX-20R (PMX cartridge)	Device	TORAYMYXIN PMX-20R (PMX cartridge), Extracorporeal hemoperfusion device. Each treatment will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 ml/minute, (range of 80 to 120 ml/minute).

Measure	Description	Time Frame
Mortality	Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone	28 days

Name	Affiliation	Role
Phillip Dellinger, Dr.	Cooper Health System	Principal Investigator

PubMed Identifier	Type	Citation	Retractions
41837287	Derived	Chanderraj R, Bartek B, Stringer KA, Tiba MH, Sjoding MW, He Y, Nuppnau M, Bongers KS, Adame MD, Lou SS, Kerschberger VE, Churpek MM, Calfee CS, Tripathi S, Foster DM, Kellum JA, Dickson RP, Sinha P. Pathogen characteristics are key determinants of distinct host response phenotypes of sepsis. J Clin Invest. 2026 Mar 16;136(6):e197346. doi: 10.1172/JCI197346. eCollection 2026 Mar 16.
30470853

ID	Title	Description
FG000	Sham	Standard medical care for septic shock
FG001	Treatment	Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock.

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0012 events2 affected212 at risk
Coagulopathy	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0010 events0 affected212 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0010 events0 affected212 at risk
Pancytopenia	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	3 events on treatment arm possibly related to PMX cartridge	EG0004 events4 affected220 at risk EG0016 events6 affected212 at risk
Acute myocardial infarction	Cardiac disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0011 events1 affected212 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0013 events3 affected212 at risk
Bradycardia	Cardiac disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0013 events2 affected212 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment		EG00014 events12 affected220 at risk EG0016 events6 affected212 at risk
Cardiac failure	Cardiac disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0012 events2 affected212 at risk
Cardiac failure congestive	Cardiac disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Cardio-respiratory arrest	Cardiac disorders	Systematic Assessment		EG0008 events8 affected220 at risk EG0012 events2 affected212 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment		EG0002 events1 affected220 at risk EG0010 events0 affected212 at risk
Cor pulmonale chronic	Cardiac disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0012 events2 affected212 at risk
Pericardial effusion	Cardiac disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Pulseless electrical activity	Cardiac disorders	Systematic Assessment		EG0003 events3 affected220 at risk EG0011 events1 affected212 at risk
Sinus bradycardia	Cardiac disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Supraventricular tachycardia	Cardiac disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0012 events2 affected212 at risk
Torsade de pointes	Cardiac disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Adrenal harmorrhage	Endocrine disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Retinal detachment	Eye disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Abdominal compartment syndrome	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0013 events2 affected212 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Enterocutaneous fistula	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Gastrointestinal disorder	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0015 events5 affected212 at risk
Haematochezia	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Intestinal perforation	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Obstructive gastric	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Oesophagal perforation	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Oesophagal varices haemorrhage	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Pancreatitis	Gastrointestinal disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0011 events1 affected212 at risk
Pancreatitis necrotising	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Cardiac Death	General disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Chest pain	General disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Death	General disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0016 events6 affected212 at risk
Device leakage	General disorders	Systematic Assessment	1 event on treatment arm probably related to PMX cartridge	EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Device malfunction	General disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Disease progression	General disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Multi-organ failure	General disorders	Systematic Assessment		EG00012 events12 affected220 at risk EG00114 events14 affected212 at risk
Terminal state	General disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Thrombosis in device	General disorders	Systematic Assessment	1 event on treatment arm definitely related to PMX cartridge	EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Acute hepatic failure	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0012 events2 affected212 at risk
Cholangitis	Hepatobiliary disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Cholecystitis acute	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Cholecystitis chronic	Hepatobiliary disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Chronic hepatic failure	General disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0010 events0 affected212 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Hepatic failure	Hepatobiliary disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0014 events4 affected212 at risk
Hepatic infarction	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Hepatorenal syndrome	Hepatobiliary disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Liver injury	Hepatobiliary disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Portal vein thrombosis	Hepatobiliary disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Abdominal sepsis	Infections and infestations	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Abscess	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Abscess neck	Infections and infestations	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Appendicitis	Infections and infestations	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Bacterial sepsis	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Biliary sepsis	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Cellulitis	Infections and infestations	Systematic Assessment		EG0001 events1 affected220 at risk EG0012 events1 affected212 at risk
Clostridium difficile colitis	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Diverticulitis	Infections and infestations	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Empyema	Infections and infestations	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Enterococcal infection	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Gangrene	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Necrotising fasciitis	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Orchitis	Infections and infestations	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Pneumonia	Infections and infestations	Systematic Assessment		EG0003 events3 affected220 at risk EG0012 events2 affected212 at risk
Postoperative wound infection	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Pulmonary sepsis	Infections and infestations	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Sepsis	Infections and infestations	Systematic Assessment		EG00023 events20 affected220 at risk EG00126 events23 affected212 at risk
Septic shock	Infections and infestations	Systematic Assessment		EG00017 events16 affected220 at risk EG00113 events13 affected212 at risk
Splenic abscess	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Staphylococcal sepsis	Infections and infestations	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Uninary tract infection	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0012 events2 affected212 at risk
Wound sepsis	Infections and infestations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Anaphylactic transfusion reaction	Injury, poisoning and procedural complications	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Brain herniation	Injury, poisoning and procedural complications	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Diaphragmatic injury	Injury, poisoning and procedural complications	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	Systematic Assessment		EG0001 events1 affected220 at risk EG0012 events1 affected212 at risk
Injury	Injury, poisoning and procedural complications	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Splenic injury	Injury, poisoning and procedural complications	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Wound evisceration	Injury, poisoning and procedural complications	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Blood lactic acid increased	Investigations	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0012 events2 affected212 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0013 events2 affected212 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Failure to thrive	Metabolism and nutrition disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Fluid overload	Metabolism and nutrition disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Hypercalcaemia	Metabolism and nutrition disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Metabolic acidosis	Metabolism and nutrition disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Crystal arthropathy	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Adrenal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Chloroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Brain injury	Nervous system disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Brain oedema	Nervous system disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Brain stem stroke	Nervous system disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Cerebral infarction	Nervous system disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0013 events2 affected212 at risk
Cerebrovascular accident	Nervous system disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0011 events1 affected212 at risk
Depressed level of consciousness	Nervous system disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Embolic stroke	Nervous system disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Haemorrhagic stroke	Nervous system disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Hepatic encephalopathy	Nervous system disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Hydrocephalus	Nervous system disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Ischaemic stroke	Nervous system disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Presyncope	Nervous system disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Subarachnoid haemorrhage	Nervous system disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Delirium	Psychiatric disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Depression	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0012 events2 affected212 at risk
Eating disorder	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Mental status change	Psychiatric disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Faecaluria	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0012 events2 affected212 at risk
Renal failure acute	Renal and urinary disorders	Systematic Assessment		EG0006 events6 affected220 at risk EG0013 events3 affected212 at risk
Renal failure chronic	Renal and urinary disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0013 events2 affected212 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0011 events1 affected212 at risk
Aspiration	Reproductive system and breast disorders	Systematic Assessment		EG0004 events3 affected220 at risk EG0011 events1 affected212 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0003 events1 affected220 at risk EG0010 events0 affected212 at risk
Epitaxis	Reproductive system and breast disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0013 events2 affected212 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0012 events2 affected212 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0014 events4 affected212 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0011 events1 affected212 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0011 events1 affected212 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0012 events2 affected212 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG00011 events10 affected220 at risk EG00110 events8 affected212 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Purpura fulminans	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Steven-Johnson syndrome	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Arteriosclerosis	Vascular disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0014 events1 affected212 at risk
Bleeding varicose vein	Vascular disorders	Systematic Assessment		EG0000 affected220 at risk EG0011 events1 affected212 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment		EG0002 events2 affected220 at risk EG0012 events2 affected212 at risk
Embolism	Vascular disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0012 events2 affected212 at risk
Embolism venous	Vascular disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Haematoma	Vascular disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Haemorrhage	Vascular disorders	Systematic Assessment		EG0002 events1 affected220 at risk EG0011 events1 affected212 at risk
Hypotension	Vascular disorders	Systematic Assessment	2 events on treatment arm probably related to PMX cartridge	EG0002 events2 affected220 at risk EG0012 events2 affected212 at risk
Infarction	Vascular disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Ischaemia	Vascular disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Peripheral ischaemia	Vascular disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk
Shock haemorrhagic	Vascular disorders	Systematic Assessment		EG0000 events0 affected220 at risk EG0011 events1 affected212 at risk
Vascular insufficiency	Vascular disorders	Systematic Assessment		EG0001 events1 affected220 at risk EG0010 events0 affected212 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D012772	Shock, Septic
D019446	Endotoxemia

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012769	Shock
D016470	Bacteremia
D014115	Toxemia

ID	Title	Description
BG000	Sham	Standard medical care for septic shock
BG001	Treatment	Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sham	Standard medical care for septic shock	78	226	126	220	60	220
EG001	Treatment	Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock.	84	224	140	212	56	212