A pilot, double-blind, randomised, placebo-controlled, exploratory study to investigate the safety and effect of Calf Intestinal Alkaline Phosphatase in patients with sepsis.
Completed
- Conditions
- Sepsis.
- Registration Number
- NL-OMON19934
- Lead Sponsor
- AM-Pharma B.V.Rumpsterweg 63981 AK BunnikTHE NETHERLANDSTelephone: +31 (0)30 228 9 222Telefax: +31 (0)30 228 9 220
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
1. Patients >= 18 years and <= 80 years;
Exclusion Criteria
1. Pregnant or lactating women;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Criteria for evaluation of safety:<br /><br>1. (Serious) adverse events;<br><br />2. Antibodies against CIAP;<br><br />3. ECG parameters;<br><br />4. Biochemical safety parameters; <br><br />5. Hematological parameters;<br><br />6. Coagulation parameters. <br /><br><br /><br /><br>Efficacy: (primary effect parameters):<br><br />7. CRP; <br><br />8. Plasma lactate;<br><br />9. Cytokines (TNF-, IL-1, IL-4, IL-6, IL-8 IL-10);<br><br />10. White cell differential cell count;<br><br />11. Procalcitonin;<br><br />12. LPS.
- Secondary Outcome Measures
Name Time Method Efficacy:(secondary effect parameters):<br><br />1. Body temperature;<br><br />2. Heart rate;<br><br />3. Blood pressure;<br><br />4. APACHE-II score;<br><br />5. Overall mortality at 28 days;<br><br />6. Length of stay at ICU;<br><br />7. Number of days requiring mechanical ventilation; <br><br />8. Length of stay in hospital;<br><br />9. Sequential organ failure assessment (SOFA);<br><br />10. Number of dysfunctional organs.