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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00159952
First received: September 7, 2005
Last updated: November 26, 2013
Last verified: February 2009
  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 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Policlinico Hospital

Additional 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:
Sepsis
Septic shock
Hyperglycemia
Fibrinolysis
PAI 1

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

ClinicalTrials.gov processed this record on July 09, 2014