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Study stopped for operational futility. Due to very small numbers of subjects, insufficient data was available for results to provide meaningful conclusions.
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The purpose of this study is to determine if Selective Adsorption System for Removal of Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.
Is extracorporeal treatment effective in the treatment of sepsis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | S.A.F.E.BT plus Standard of Care therapy |
|
| Group B | No Intervention | Standard of Care therapy alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S.A.F.E.BT | Device | Five (5) S.A.F.E.BT treatments within a 7 day treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | The primary outcome measure is the average of all changes in daily SOFA scores from baseline through Day 8. The SOFA score indicates quantitatively, and as objectively as possible, the degree of organ dysfunction/failure by describing a sequence of complications in the critically ill. SOFA score consists of classifications for six (6) organ functions: Respiratory, Cardiovascular, Coagulation, CNS, Liver, and Renal. Each function is assigned a value from 0 (normal organ function) to 4 (most abnormal organ function). Each subject's 6 organ function SOFA scores are summed to become a single daily SOFA score (total score range: 0-24, where 24 is the maximum score associated with the most abnormal function and worst outcomes). A higher SOFA score on Day 2 compared to Day 1 indicates more abnormal organ functions and a worsening physical condition. | Baseline through Day 8 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert Wilkins, MBChB FRCA | BBraun Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States | ||
| University of Maryland Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | S.A.F.E.BT plus Standard of Care therapy S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period. |
| FG001 | Group B | Standard of Care therapy alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | S.A.F.E.BT plus Standard of Care therapy S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period. |
| BG001 | Group B | Standard of Care therapy alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | The primary outcome measure is the average of all changes in daily SOFA scores from baseline through Day 8. The SOFA score indicates quantitatively, and as objectively as possible, the degree of organ dysfunction/failure by describing a sequence of complications in the critically ill. SOFA score consists of classifications for six (6) organ functions: Respiratory, Cardiovascular, Coagulation, CNS, Liver, and Renal. Each function is assigned a value from 0 (normal organ function) to 4 (most abnormal organ function). Each subject's 6 organ function SOFA scores are summed to become a single daily SOFA score (total score range: 0-24, where 24 is the maximum score associated with the most abnormal function and worst outcomes). A higher SOFA score on Day 2 compared to Day 1 indicates more abnormal organ functions and a worsening physical condition. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | scores on a scale | Baseline through Day 8 |
|
28 days per subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | S.A.F.E.BT plus Standard of Care therapy S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
This study did not reach the target number of participants needed to achieve target power and statistically reliable results leading to unreliable or uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diana Velencia, Associate Director of Clinical Affairs | B. Braun Medical Inc. | 610-596-2875 | diana.valencia@bbraunusa.com |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| Group A |
S.A.F.E.BT plus Standard of Care therapy S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period. |
| OG001 | Group B | Standard of Care therapy alone |
|
|
| 1 |
| 9 |
| 2 |
| 9 |
| 9 |
| 9 |
| EG001 | Group B | Standard of Care therapy alone | 1 | 7 | 5 | 7 | 7 | 7 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdonimal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Upper gi haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Impaired Healing | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Local Swelling | General disorders | MedDRA 17.0 | Systematic Assessment | Administration Site Condition |
|
| Pain | General disorders | MedDRA 17.0 | Systematic Assessment | Administration Site Condition |
|
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Brucellosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood alkaline phosphate increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Carbon dioxide increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Skin operation | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Poor peripheral circulation | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
Study sites are able to publish on their own data if Sponsor does not publish a multi-center study paper within 18 months after trial completion.
Sites agree to submit any proposed publication, presentation or other public disclosure to Sponsor for review at least 30 days prior to submitting to a publisher or other 3rd party. Within 30 days of receipt, Sponsor shall advise removal of any confidential information or which may impair Sponsor's ability to obtain patent protection.
| D013568 |
| Pathological Conditions, Signs and Symptoms |