Status:
COMPLETED
Effects of Alkaline Phosphatase on Renal Function in Septic Patients
Lead Sponsor:
Radboud University Medical Center
Conditions:
Severe
Septic
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Septic shock is the most common cause of death in patients requiring intensive care. The kidney is one of the first organs to fail, stressing the importance to search for clinical interventions that m...
Eligibility Criteria
Inclusion
- Written informed consent
- Proven or suspected Gram-negative bacterial infection
- Two out of four Systemic Inflammatory Response Syndrome (SIRS) criteria existing for less than 24 h
- Acute onset of end-organ dysfunction in the preceding 12 h
Exclusion
- Prior therapy with alkaline phosphatase
- Known allergy for cow milk
- Probable death within 24 h
- Chronic renal failure requiring hemodialysis or peritoneal dialysis
- Acute pancreatitis with no established source of infection
- HIV seropositive
- Pregnant or lactating
- Confirmed Gram-positive or fungal sepsis
- Treatment with immunosuppressants including high doses of glucocorticosteroids
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00457613
Start Date
November 1 2004
End Date
March 1 2006
Last Update
April 6 2007
Active Locations (1)
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1
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands