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NCT Number: NCT00457613

Effects of Alkaline Phosphatase on Renal Function in Septic Patients

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.

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Key information

Conditions

Severe Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Inflammation Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radboud University Medical Centre

Nijmegen, Gelderland, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. Biomarkers of kidney damage

  2. kidney function

  3. markers of inflammation

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Apr 6, 2007
Registry last updated
Apr 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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