Clinical Trials Directory

Trials / Completed

CompletedNCT00457613

Effects of Alkaline Phosphatase on Renal Function in Septic Patients

Effects of Alkaline Phosphatase on Renal Function in Patients With Severe Sepsis or Septic Shock.

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
15 (planned)
Sponsor
Radboud University Medical Center · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGbolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)

Timeline

Start date
2004-11-01
Completion
2006-03-01
First posted
2007-04-06
Last updated
2007-04-06

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT00457613. Inclusion in this directory is not an endorsement.