SeverePhase 2NCT00457613
Effects of Alkaline Phosphatase on Renal Function in Septic Patients
A Phase 2 study testing bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase) in people with Severe and Septic, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2004to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or lactating
- Confirmed Gram-positive or fungal sepsis
- Treatment with immunosuppressants including high doses of glucocorticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Alkaline Phosphatase on Renal Function in Patients With Severe Sepsis or Septic Shock.
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.
- Being tested
- bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)
- Keywords
- alkaline phosphatase, sepsis, kidney function
- Medical subject headings
- Lymphoma, Follicular, Shock, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of kidney damage
kidney function
markers of inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startNov 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SevereStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Peter Pickkers, MD, PhD, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457613
- Sponsor's protocol ID
- PP05
- Status last verified
- Mar 2006
- First submitted
- 4 Apr 2007
- Last updated
- 6 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alkaline Phosphatase on Renal Function in Patients With Severe Sepsis or Septic Shock.
- ClinicalTrials.gov ID
- NCT00457613
- Acronym / sponsor ID
- PP05
- Keywords
- alkaline phosphatase, sepsis, kidney function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Mar 2006
- First posted
- 6 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase) | Drug | – |
Primary outcome
Biomarkers of kidney damage
kidney function
markers of inflammation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Pickkers, MD, PhD study director
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase) in people with Severe and Septic, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of kidney damage. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2007.