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The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00282594
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : January 27, 2006
Novo Nordisk A/S
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Brief Summary:
We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.

Condition or disease Intervention/treatment Phase
Sepsis Respiratory Failure Renal Failure Surgical Site Infection Drug: Novolin R (human recombinant Insulin) Not Applicable

Detailed Description:
While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population

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Study Type : Interventional  (Clinical Trial)
Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.
Study Start Date : July 2003
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Primary Outcome Measures :
  1. Mortality

Secondary Outcome Measures :
  1. Length of ICU Stay
  2. Ventilatory Requirement
  3. Vasopressor Support
  4. Incidence of Renal Failure
  5. Incidence of Wound Infection

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Patients undergoing a general or vascular surgical procedure requiring admission to the surgical intensive care unit as a result of ventilatory requirement, vasopressor support, or physiologic instability


Exclusion Criteria:

  • Under age 18

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 identifier (NCT number): NCT00282594

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United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Novo Nordisk A/S
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Principal Investigator: Michael Kia, DO Genesys Regional Medical Center

Layout table for additonal information Identifier: NCT00282594     History of Changes
Other Study ID Numbers: GRMC 050023
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: January 27, 2006
Last Verified: November 2005

Keywords provided by Genesys:
Intensive Insulin Therapy
General Surgical
Vascular Surgical
Tight Glycemic Control

Additional relevant MeSH terms:
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Renal Insufficiency
Respiratory Insufficiency
Surgical Wound Infection
Kidney Diseases
Urologic Diseases
Respiration Disorders
Respiratory Tract Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs