Sepsis.
Conditions
Interventions
Patients will be assigned to receive either CIAP or placebo administered intravenously over 24 hours.
Patients randomized to CIAP will receive an initial bolus injection of 67.5 U/kg body weight admi
Sponsors
AM-Pharma B.V.
Rumpsterweg 6
3981 AK Bunnik
THE NETHERLANDS
Telephone: +31 (0)30 228 9 222
Telefax: +31 (0)30 228 9 220
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients >= 18 years and = 38 or = 90 beats/min (unless the patient has a medical condition known to increase heart rate or is receiving treatment that would prevent tachycardia); c. Respiratory rate >= 20 breaths/min, a PaCO2 = 12.000/mm3 or 10 percent immature neutrophils; 4. Acute onset of end-organ dysfunction in the preceding 12 hours unrelated to the primary septic focus and not explained by any underlying chronic disease as indicated ≥ 1 (one or more) of the following: 4.1 Sustained hypotension or organ dysfunction that is the result of sepsis and not the patient’s underlying disease or treatment, as evidenced by one or more of the following criteria for less than 12 hours: 4.1.a Systolic blood pressure = 177 μmol/l (2.0 mg/dl) within the previous 48 hours, in the absence of primary underlying renal disease. 4.3 Acute alteration in mental state not due to sedation or of primary underlying disease of the central nervous system. 4.4 Acute hypoxemic respiratory failure, defined by a PaO2(/FiO2 ratio = -5 mmol/L in association with a plasma lactate >= 3.0 mmol/L 4.7 Acute hepatic failure, defined by at least 2 of the following criteria, in absence of primary underlying hepatic disease: 4.7.a Serum bilirubin concentration > 43 µmol/l (2.5 mg/dl) 4.7.b Serum ALAT/ASAT concentration > twice the upper limit of normal range 4.7.c Prothrombin time > 1.5 times the control value or an International Normalized Ratio > 1.5 in the absence of systemic anticoagulation 5. Written informed consent obtained.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Known HIV seropositive patients; 3. Patients receiving immunosuppressive therapy or high doses of glucocortico steroids (defined as > 1 mg/kg/day) equivalent to prednisone 1 mg/kg/day; 4. Patients expected to have rapidly fatal disease within 24 hours; 5. Known confirmed gram-positive sepsis; 6. Known confirmed fungal sepsis; 7. Chronic renal failure requiring hemodialysis or peritoneal dialysis; 8. Acute pancreatitis with no established source of infection; 9. Patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm or other diseases; 10. Participation in another investigational study within 90 days prior to start of the study which might interfere with this study; 11. Previous administration of CIAP; 12. Known allergy for cowmilk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Criteria for evaluation of safety: 1. (Serious) adverse events; 2. Antibodies against CIAP; 3. ECG parameters; 4. Biochemical safety parameters; 5. Hematological parameters; 6. Coagulation parameters. Efficacy: (primary effect parameters): 7. CRP; 8. Plasma lactate; 9. Cytokines (TNF-, IL-1, IL-4, IL-6, IL-8 IL-10); 10. White cell differential cell count; 11. Procalcitonin; 12. LPS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy:(secondary effect parameters): 1. Body temperature; 2. Heart rate; 3. Blood pressure; 4. APACHE-II score; 5. Overall mortality at 28 days; 6. Length of stay at ICU; 7. Number of days requiring mechanical ventilation; 8. Length of stay in hospital; 9. Sequential organ failure assessment (SOFA); 10. Number of dysfunctional organs. | — |
Contacts
Public ContactAM-Pharma B.V.
Rumpsterweg 6
Outcome results
None listed