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

Sepsis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282594
• Other study ID #: GRMC 050023
• Status: Completed
• Phase: N/A
• First received: January 26, 2006
• Last updated: January 26, 2006
• Start date: July 2003
• Est. completion date: October 2005

Study information

• Verified date: November 2005
• Source: Genesys
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Failure
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Novolin R (human recombinant Insulin)

Locations

Country	Name	City	State
United States	Genesys Regional Medical Center	Grand Blanc	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Genesys	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality
Secondary	Length of ICU Stay
Secondary	Ventilatory Requirement
Secondary	Vasopressor Support
Secondary	Incidence of Renal Failure
Secondary	Incidence of Wound Infection