Effects of Alkaline Phosphatase on Renal Function in Septic Patients
|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.|
|ClinicalTrials.gov Identifier: NCT00457613|
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : April 6, 2007
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 or disease||Intervention/treatment||Phase|
|Severe Septic Shock||Drug: bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effects of Alkaline Phosphatase on Renal Function in Patients With Severe Sepsis or Septic Shock.|
|Study Start Date :||November 2004|
|Study Completion Date :||March 2006|
- Biomarkers of kidney damage
- kidney function
- markers of inflammation
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
|Radboud University Medical Centre|
|Nijmegen, Gelderland, Netherlands|
|Study Director:||Peter Pickkers, MD, PhD||Radboud University|