Effects of Alkaline Phosphatase on Renal Function in Septic Patients

Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457613
• Other study ID #: PP05
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2007
• Last updated: April 5, 2007
• Start date: November 2004
• Est. completion date: March 2006

Study information

• Verified date: March 2006
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic
• Severe
• Shock

Intervention

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

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of kidney damage
Primary	kidney function
Primary	markers of inflammation