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

Primary Purpose

Critical Illness, Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulin
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Outcomes

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]

Full Information

First Posted
September 12, 2005
Last Updated
April 15, 2011
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00166491
Brief Title
Comparing Two Ways of Controlling Blood Sugar With Insulin in Patients Admitted to the Intensive Care Unit
Official Title
Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients admitted to the 7MB D/E ICU will be eligible for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy K. Tuhin, M.D., Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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