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

NCT00159952 | Completed Phase 2

• 3 other identifiers: 3133Lilly F1K0020MIUR 2004060419
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Severe Sepsis; Septic Shock

Keywords

Sepsis; Septic shock; Hyperglycemia; Fibrinolysis; PAI 1

Outcome Measures

Primary Outcomes (1)

• The primary end-point is the evaluation of the activation/deactivation of the fibrinolytic system in the two randomization group

  At Baseline and every 24 hour

Secondary Outcomes (2)

• To evaluate the different organ dysfunctions (pulmonary, hepatic and volemic status)

  28 days survival

• The effect of the treatment

  28 days survival

Study Arms (1)

1

ACTIVE COMPARATOR

Procedure: intensive insulin therapy

Interventions

intensive insulin therapy PROCEDURE

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

1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Policlinico Hospital: lead
• Eli Lilly and Company: collaborator

Study Sites (3)

Hospital "S.Paolo"

Milan, Italy

Location

Policlinico Hospital

Milan, Italy

Location

Hospital "S.Gerardo"

Monza, Italy

Location

Related Publications (1)

• Savioli M, Cugno M, Polli F, Taccone P, Bellani G, Spanu P, Pesenti A, Iapichino G, Gattinoni L. Tight glycemic control may favor fibrinolysis in patients with sepsis. Crit Care Med. 2009 Feb;37(2):424-31. doi: 10.1097/CCM.0b013e31819542da.

  PMID: 19114908 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic; Hyperglycemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Luciano Gattinoni, MD

  Policlinico Hospital of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: November 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 27, 2013

Record last verified: 2009-02

Locations

IT (3)