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

Sponsors and Collaborators:	Policlinico Hospital Eli Lilly and Company
Information provided by:	Policlinico Hospital
ClinicalTrials.gov Identifier:	NCT00159952

Purpose

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 we 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 II Phase III

MedlinePlus related topics: Sepsis

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Hyperglycemia in PAI-1 Activity and the Relationship With Outcome in Severe Sepsis and Septic Shock

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

Arms	Assigned Interventions
1: Active Comparator	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

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Eligibility

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

Criteria

Inclusion Criteria:

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159952

Locations

Italy
Policlinico Hospital
milan, Italy
Hospital "S.Paolo"
Milan, Italy
Hospital "S.Gerardo"
Monza, Italy

Sponsors and Collaborators

Policlinico Hospital

Eli Lilly and Company

Investigators

Principal Investigator:

Luciano Gattinoni, MD

Policlinico Hospital of Milan

More Information

Responsible Party:	Policlinico Hospital ( Luciano Gattinoni )
Study ID Numbers:	3133, Lilly F1K0020, MIUR 2004060419
Study First Received:	September 7, 2005
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00159952
Health Authority:	Italy: Ministry of Health

Keywords provided by Policlinico Hospital:

Sepsis
Septic shock
Hyperglycemia
Fibrinolysis
PAI 1

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Metabolic Diseases
Hyperglycemia
Shock
Shock, Septic

Plasminogen Activator Inhibitor 1
Metabolic disorder
Glucose Metabolism Disorders
Insulin
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 14, 2009