drugset / Trial / NCT00457613

Effects of Alkaline Phosphatase on Renal Function in Septic Patients

NCT00457613 ↗

Phase 2 Completed 15 enrolled Radboud University Medical Center
RandomizedParallel-groupDouble-blindTreatment

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 may protect the kidneys during sepsis. Alkaline phosphatase functions as a host defence molecule and is present in many cells and organs (e.g. intestine, placenta, liver, kidney and bone). Alkaline phosphatase has a dual mode of action. First, it binds to and, subsequently, dephosphorylates lipopolysaccharide (LPS). Second, the enzymatic reaction product monophosphoryl-LPS is a non-toxic substance for mammals which acts as a partial antagonist on the LPS receptor complex. In several animal studies, administration of alkaline phosphatase attenuates the inflammatory response and reduces mortality. It is unknown whether these results can be extrapolated to septic patients . We studied the effects of alkaline phosphatse administration on kidney damage and function in patients with severe sepsis or septic shock.

Timeline

Start
2004-11
Primary completion
—
Completion
2006-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Alkaline Phosphatase Protein / enzyme biologic — —

Indications