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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk
Information provided by:
Genesys
ClinicalTrials.gov Identifier:
NCT00282594
First received: January 26, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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 Intervention
Sepsis
Respiratory Failure
Renal Failure
Surgical Site Infection
 Drug: Novolin R (human recombinant Insulin)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genesys:

Primary Outcome Measures:
  • Mortality

Secondary Outcome Measures:
  • Length of ICU Stay
  • Ventilatory Requirement
  • Vasopressor Support
  • Incidence of Renal Failure
  • Incidence of Wound Infection

Estimated Enrollment: 317
Study Start Date: July 2003
Estimated Study Completion Date: October 2005
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282594

Locations
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Genesys
Novo Nordisk
Investigators
Principal Investigator: Michael Kia, DO Genesys Regional Medical Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00282594     History of Changes
Other Study ID Numbers: GRMC 050023
Study First Received: January 26, 2006
Last Updated: January 26, 2006
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Renal Insufficiency
Sepsis
Respiratory Insufficiency
Kidney Diseases
Urologic Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013