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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-10-31

Brief Summary

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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

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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

Conditions

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Sepsis Respiratory Failure Renal Failure Surgical Site Infection

Keywords

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Intensive Insulin Therapy General Surgical Vascular Surgical Tight Glycemic Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Novolin R (human recombinant Insulin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Under age 18

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michael Kia, DO

Role: PRINCIPAL_INVESTIGATOR

Ascension Health

Locations

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Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 11794168 (View on PubMed)

Other Identifiers

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GRMC 050023

Identifier Type: -

Identifier Source: org_study_id