Status:
COMPLETED
Bovine Intestinal Alkaline Phosphatase for the Treatment of Patients With Sepsis
Lead Sponsor:
AM-Pharma
Conditions:
Sepsis
Multiple Organ Dysfunction Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Eligible patients will receive either AP or matching placebo in a double blind, randomized design and following a 2:1 ratio. All medication will be given in addition to standard care for sepsis patien...
Detailed Description
Both bolus and continuous infusions were found to effectively reduce the LPS-induced pro-inflammatory cytokine TNFα in piglets. When AP was administered as a bolus (160 U/kg), the reduction of TNFα af...
Eligibility Criteria
Inclusion
- Patients between 18 and 80 years (inclusive);
- proven or suspected infection;
- meeting 2 of 4 of the systemic inflammatory response syndrome (SIRS) criteria;
- septic shock or one or more acute organ failures in the preceding 12 hours;
- written informed consent obtained.
Exclusion
- Pregnant or lactating women;
- known HIV seropositive patients;
- patients receiving immunosuppressive therapy or chronically using high doses of glucocorticosteroids (defined as \> 1 mg/kg/day) equivalent to prednisone 1 mg/kg/day;
- patients expected to have rapidly fatal disease within 24 h;
- known confirmed gram-positive sepsis;
- known confirmed fungal sepsis;
- chronic renal failure requiring haemodialysis or peritoneal dialysis;
- acute pancreatitis with no established source of infection;
- patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm or other diseases;
- participation in another investigational study within 90 days prior to start of the study which might interfere with this study;
- previous administration of AP;
- known allergy for cow milk.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00430859
Start Date
September 1 2004
End Date
March 1 2006
Last Update
April 2 2012
Active Locations (10)
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1
Hospital Network Antwerpen - Middelheim
Antwerp, Antwerpen, Belgium, B-2020
2
University Hospital Antwerpen
Antwerp, Antwerpen, Belgium, B-2650
3
University Hospital Vrije Universiteit Brussel
Brussels, Brussels Capital, Belgium, B-1090
4
University Medical Centre St. Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB