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OpenTrials
Completed

NCT Number: NCT00282594

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

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.

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Key information

Conditions

Sepsis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Renal Failure Renal Insufficiency Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Surgical Site Infection Surgical Wound Infection Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novolin R (human recombinant Insulin)

Drug

Primary outcomes

  1. Mortality

Secondary outcomes

  1. Length of ICU Stay

  2. Ventilatory Requirement

  3. Vasopressor Support

  4. Incidence of Renal Failure

  5. Incidence of Wound Infection

Sponsors and collaborators

Lead sponsor

Genesys

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Jan 27, 2006
Registry last updated
Jan 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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