Status:
COMPLETED
Effect of Hyperglycemia in PAI-1 Activity and the Relationship With Outcome in Severe Sepsis and Septic Shock
Lead Sponsor:
Policlinico Hospital
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine the effect of the intensive insulin therapy on coagulation and fibrinolysis in patients affected by severe sepsis and septic shock. As a secondary endpoints t...
Detailed Description
BACKGROUND The treatment of the sepsis can be done at three different level: 1. Etiologic therapy. The eradication of the infectious agent is the primary end-point. An appropriate surgical treatment...
Eligibility Criteria
Inclusion
- Patients with sepsis, severe sepsis and sepsis shock defined as follows:
- Sepsis:
- Systemic response to infection with two or more of the following conditions:
- Body temperature\<36° or \>38°
- Heart rate \>90 bpm
- Respiratory rate \>20 bpm or PaCO2\<32 torr
- White cells count\>12000 mm3 or \<4000 mm3 or a differential count showing\>10% of immature neutrophiles
- Severe sepsis:
- Sepsis associated to a organ dysfunction.
- Sepsis shock:
- Sepsis associated to hypotension despite adequate fluid resuscitation, with hypoperfusion including lactic acidosis, oliguria and acute alteration of consciousness. The hypotension does not need to be present in patients treated with inotropic or vasoactive drugs.
Exclusion
- Age below 16 years
- Patients with hematologic malignancy or bone marrow transplant
- Patients with type I diabetes
- Patients with expected early death because of underlying disease.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00159952
Start Date
November 1 2004
End Date
November 1 2007
Last Update
November 27 2013
Active Locations (3)
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1
Hospital "S.Paolo"
Milan, Italy
2
Policlinico Hospital
Milan, Italy
3
Hospital "S.Gerardo"
Monza, Italy