Effect of Hyperglycemia in PAI-1 Activity and the Relationship With Outcome in Severe Sepsis and Septic Shock

This study has been completed.
Eli Lilly and Company
Information provided by:
Policlinico Hospital
ClinicalTrials.gov Identifier:
First received: September 7, 2005
Last updated: November 26, 2013
Last verified: February 2009
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 the investigators will determine the effect of intensive insulin therapy on organ dysfunction and mortality of these patients.

Condition Intervention Phase
Severe Sepsis
Septic Shock
Procedure: intensive insulin therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Hyperglycemia in PAI-1 Activity and the Relationship With Outcome in Severe Sepsis and Septic Shock

Resource links provided by NLM:

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:
  • The primary end-point is the evaluation of the activation/deactivation of the fibrinolytic system in the two randomization group [ Time Frame: At Baseline and every 24 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the different organ dysfunctions (pulmonary, hepatic and volemic status) [ Time Frame: 28 days survival ] [ Designated as safety issue: No ]
  • The effect of the treatment [ Time Frame: 28 days survival ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2004
Study Completion Date: November 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: intensive insulin therapy

control: glycemia will be controlled with insulin administration when higher than 215 mg/dL.

treatment: glycemia will be controlled with be controlled with insulin administration when higher than 110 mg/dL

  Show Detailed Description


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with sepsis, severe sepsis and sepsis shock defined as follows:


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 Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00159952

Hospital "S.Paolo"
Milan, Italy
Policlinico Hospital
Milan, Italy
Hospital "S.Gerardo"
Monza, Italy
Sponsors and Collaborators
Policlinico Hospital
Eli Lilly and Company
Principal Investigator: Luciano Gattinoni, MD Policlinico Hospital of Milan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luciano Gattinoni, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00159952     History of Changes
Other Study ID Numbers: 3133  Lilly F1K0020  MIUR 2004060419 
Study First Received: September 7, 2005
Last Updated: November 26, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Policlinico Hospital:
Septic shock

Additional relevant MeSH terms:
Shock, Septic
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on May 26, 2016