Effects of Alkaline Phosphatase on Renal Function in Septic Patients

Radboud University Medical Center

Status and phase

Completed

Phase 2

Conditions

Septic

Shock

Severe

Treatments

Drug: bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)

Study type

Interventional

Funder types

Other

Identifiers

NCT00457613

PP05

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria