Severe sepsis and septic shock
Conditions
Interventions
Product Name: Alkaline Phosphatase
Product Code: AP
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intrave
Sponsors
AM-Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical defined sepsis: • Proven or suspected bacterial infection and • Minimally 2 out of 4 SIRS criteria of systemic inflammation positive: Acute onset of at least 1 end-organ dysfunction in the preceding 36 hours: • unrelated to the primary septic focus and • not explained by any underlying primary chronic disease and • as described by at least one of the following 7 underlying conditions: 1. Sustained hypotension 2. Acute renal failure 3. Acute alteration in mental state 4. Acute hypoxemic respiratory failure 5. Disseminated intravascular coagulopathy (DIC) 6. Metabolic acidosis 7. Acute hepatic failure at least 18 years Body weight = 125 kg Being committed to - and treated with full intensive care support Written informed consent obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients being treated for transplantation of bone marrow, lung, liver, pancreas or other condition. 2. Known confirmed gram-positive sepsis. 3. Known confirmed fungal sepsis. 4. Chronic renal failure requiring hemodialysis or peritoneal dialysis. 5. Acute pancreatitis with no established source of infection. 6. Patients expected to have rapidly fatal disease within 24 hours . 7. Patients not expected to survive for 28 days, due to other medical conditions such as end-stage neoplasm or other diseases. 8. Patients being treated with cancer related chemotherapy. 9. Participation in another investigational study which clearly and documented interferes with this study, within 30 days prior to start of the study . 10. Previous administration of AP. 11. Allergy for cow milk. 12. Known HIV patients with CD4-count < 50. 13. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the clinical efficacy on 28 day all cause mortality and survival rate of a high and a low dosage of iv Alkaline Phosphatase (AP) in comparison to placebo in patients with severe sepsis and septic shock;Secondary Objective: To investigate the effect of a high and low dosage of AP in comparison to placebo in patients with severe sepsis and septic shock, on clinical efficacy variables like: • Day 28 clinical condition • Per patient variable: Change from baseline of APACHE II- score and SOFA score. ICU and hospital length of stay. Number of days on mechanical ventilation and/or extra-renal support. To investigate the effect of a high and low dosage of AP in comparison to placebo in patients with severe sepsis and septic shock, on surrogate efficacy variables like: Per patient change from baseline of: Inflammation variables. Pharmacokinetics. Immunological variables. To investigate the safety and tolerability of a high and low AP dosage in comparison to placebo, in patients with severe sepsis and septic shock ;Primary end point(s): 28 day all cause mortality and survival rate | — |
Countries
Belgium
Outcome results
None listed