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Comparing Two Ways of Controlling Blood Sugar With Insulin in Patients Admitted to the Intensive Care Unit

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166491
First received: September 12, 2005
Last updated: April 15, 2011
Last verified: April 2011

September 12, 2005
April 15, 2011
July 2005
March 2007   (final data collection date for primary outcome measure)
  • Percentage of time points within range during protocol (serum glucose 60-150 mg/dl) [%]
  • Mean blood glucose level during study period [mg/dl]
  • 1. Percentage of time points within range during protocol (serum glucose 60-150 mg/dl) [%]
  • 2.Mean blood glucose level during study period [mg/dl]
Complete list of historical versions of study NCT00166491 on ClinicalTrials.gov Archive Site
  • Time from initiation of protocol to first measurement in target range (serum glucose 60-150 mg/dl) [hours]
  • Number of time points below range (hypoglycemic episodes with serum glucose < 60) normalized by study period [hypoglycemic glucose determinations/total glucose determinations]
  • Time enrolled in the trial [hours]
  • Maximum blood glucose level during study period [mg/dl]
  • Mean hourly intravenous (IV) insulin dose calculated daily [units/hour]
  • 1.Time from initiation of protocol to first measurement in target range (serum glucose 60-150 mg/dl) [hours]
  • 2.Number of time points below range (hypoglycemic episodes with serum glucose <60) normalized by study period [hypoglycemic glucose determinations/total glucose determinations]
  • 3.Time enrolled in the trial [hours]
  • 4.Maximum blood glucose level during study period [mg/dl]
  • 5.Mean hourly IV insulin dose calculated daily [units/hour]
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Comparing Two Ways of Controlling Blood Sugar With Insulin in Patients Admitted to the Intensive Care Unit
Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients

The purpose of this study is to determine if there is any difference between two ways of controlling blood sugar with insulin. In patients admitted to the intensive care unit, blood sugar levels often rise due to the stress of illness or surgery. Studies have shown that patients do better if their blood sugar is kept normal. In order to maintain normal blood sugar levels, the investigators often give insulin (a substance made by the body), and they decide how much to give based on how high the blood sugar is. This study will compare two different ways of deciding how much insulin to give and compare how well each method keeps the blood sugar in a normal range. Both ways of controlling blood sugar are institutionally-approved protocols and part of routine care.

Improved outcomes have been demonstrated with tight control of blood glucose in critically ill patients. A number of look-up algorithms based on hourly glucose measurements and titrated intravenous insulin have been developed for the intensive care unit (ICU). Despite the numerous published algorithms, no study has investigated which algorithm results in optimal glycemic control in critically ill patients. The purpose of this trial is to compare two institutionally approved intravenous insulin administration algorithms and describe subsequent glycemic control. We hypothesize that the protocol that allows for variable insulin administration for a given blood glucose (multiple algorithms) will be associated with more optimal glycemic control. Optimal glycemic control will be defined by time spent within a predetermined blood glucose range. In addition, the number of hypoglycemic episodes and mean and maximum blood glucose concentrations will also be measured. This trial will determine which insulin infusion algorithm is most effective in terms of glycemic control, and allow for standardization of glucose management in accordance with best practice.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Critical Illness
  • Hyperglycemia
Drug: Insulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients admitted to the 7MB D/E ICU will be eligible for this study
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00166491
22-05
Not Provided
Not Provided
Mayo Clinic
Not Provided
Principal Investigator: Roy K. Tuhin, M.D., Ph.D. Mayo Clinic
Mayo Clinic
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP