Effects of Alkaline Phosphatase on Renal Function in Septic Patients

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00457613
First received: April 4, 2007
Last updated: April 5, 2007
Last verified: March 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00457613     History of Changes
Other Study ID Numbers: PP05
Study First Received: April 4, 2007
Last Updated: April 5, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
alkaline phosphatase
sepsis
kidney function

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014