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

No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00282594
Enrollment
317
Registered
2006-01-27
Start date
2003-07-31
Completion date
2005-10-31
Last updated
2006-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure, Respiratory Failure, Sepsis, Surgical Site Infection

Keywords

Intensive Insulin Therapy, General Surgical, Vascular Surgical, Tight Glycemic Control

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

Interventions

DRUGNovolin R (human recombinant Insulin)

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
Genesys
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Mortality

Secondary

MeasureTime frame
Length of ICU Stay
Ventilatory Requirement
Vasopressor Support
Incidence of Renal Failure
Incidence of Wound Infection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026