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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
History of Changes
  Purpose

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.


Condition Intervention
Critical Illness
Hyperglycemia
 Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Percentage of time points within range during protocol (serum glucose 60-150 mg/dl) [%]
  • Mean blood glucose level during study period [mg/dl]

Secondary Outcome Measures:
  • 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]

Enrollment: 238
Study Start Date: July 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted to the 7MB D/E ICU will be eligible for this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166491

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Roy K. Tuhin, M.D., Ph.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00166491     History of Changes
Other Study ID Numbers: 22-05
Study First Received: September 12, 2005
Last Updated: April 15, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
 Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013