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

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ClinicalTrials.gov Identifier: NCT00159952
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 27, 2013
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Policlinico Hospital

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 the investigators will determine the effect of intensive insulin therapy on organ dysfunction and mortality of these patients.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Procedure: intensive insulin therapy Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Hyperglycemia in PAI-1 Activity and the Relationship With Outcome in Severe Sepsis and Septic Shock
Study Start Date : November 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the different organ dysfunctions (pulmonary, hepatic and volemic status) [ Time Frame: 28 days survival ]
  2. The effect of the treatment [ Time Frame: 28 days survival ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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): NCT00159952


Locations
Italy
Hospital "S.Paolo"
Milan, Italy
Policlinico Hospital
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

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
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: February 2009

Keywords provided by Policlinico Hospital:
Sepsis
Septic shock
Hyperglycemia
Fibrinolysis
PAI 1

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Hyperglycemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs