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Effects of Alkaline Phosphatase on Renal Function in Septic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457613
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University
  Purpose

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.


Condition Intervention Phase
Severe Septic Shock Drug: bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Alkaline Phosphatase on Renal Function in Patients With Severe Sepsis or Septic Shock.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Biomarkers of kidney damage
  • kidney function
  • markers of inflammation

Estimated Enrollment: 15
Study Start Date: November 2004
Estimated Study Completion Date: March 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457613


Locations
Netherlands
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Study Director: Peter Pickkers, MD, PhD Radboud University
  More Information

ClinicalTrials.gov Identifier: NCT00457613     History of Changes
Other Study ID Numbers: PP05
First Submitted: April 4, 2007
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
Last Verified: March 2006

Keywords provided by Radboud University:
alkaline phosphatase
sepsis
kidney function