Back to resultsThe Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit
Primary Purpose
Sepsis, Respiratory Failure, Renal Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novolin R (human recombinant Insulin)
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Intensive Insulin Therapy, General Surgical, Vascular Surgical, Tight Glycemic Control
Eligibility 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
Sites / Locations
- Genesys Regional Medical Center
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Length of ICU Stay
Ventilatory Requirement
Vasopressor Support
Incidence of Renal Failure
Incidence of Wound Infection
Full Information
NCT ID
NCT00282594
First Posted
January 26, 2006
Last Updated
January 26, 2006
Sponsor
Genesys
Collaborators
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT00282594
Brief Title
The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit
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 Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genesys
Collaborators
Novo Nordisk A/S
4. Oversight
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Respiratory Failure, Renal Failure, Surgical Site Infection
Keywords
Intensive Insulin Therapy, General Surgical, Vascular Surgical, Tight Glycemic Control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
317 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Novolin R (human recombinant Insulin)
Primary Outcome Measure Information:
Title
Mortality
Secondary Outcome Measure Information:
Title
Length of ICU Stay
Title
Ventilatory Requirement
Title
Vasopressor Support
Title
Incidence of Renal Failure
Title
Incidence of Wound Infection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kia, DO
Organizational Affiliation
Ascension Genesys Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11794168
Citation
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
Results Reference
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Learn more about this trial
The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit
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