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

Critical Illness Clinical Trial

Official title:

Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166491
• Other study ID #: 22-05
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: April 15, 2011
• Start date: July 2005
• Est. completion date: March 2007

Study information

• Verified date: April 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• All patients admitted to the 7MB D/E ICU will be eligible for this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycemia

Intervention

Drug:
• Insulin

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time points within range during protocol (serum glucose 60-150 mg/dl) [%]
Primary	Mean blood glucose level during study period [mg/dl]
Secondary	Time from initiation of protocol to first measurement in target range (serum glucose 60-150 mg/dl) [hours]
Secondary	Number of time points below range (hypoglycemic episodes with serum glucose < 60) normalized by study period [hypoglycemic glucose determinations/total glucose determinations]
Secondary	Time enrolled in the trial [hours]
Secondary	Maximum blood glucose level during study period [mg/dl]
Secondary	Mean hourly intravenous (IV) insulin dose calculated daily [units/hour]