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Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

Primary Purpose

Hyperglycemia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperglycemia Protocol Procedure
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia

Eligibility Criteria

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

Inclusion Criteria: Valid physician order of the protocol. - Exclusion Criteria: No valid phycician order for the protocol -

Sites / Locations

  • Morristown Memorial hospital

Outcomes

Primary Outcome Measures

1) to evaluate the effect a subcutaneous insulin aspart hyperglycemia protocol on overall glycemic control in an ICU.
2) to evaluate the effect an insulin aspart hyperglycemia protocol has on controlling blood glucoses as compared with past practices of a regular insulin regimen.
3) to assess the effect a hyperglycemis i9nsulin aspart protocol has on patient outcomes in this ICU

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
February 2, 2006
Sponsor
Atlantic Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00206206
Brief Title
Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart
Official Title
Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Atlantic Health System

4. Oversight

5. Study Description

Brief Summary
In response to the evidence supporting "tight" glucose control (70 - 110) in the critical care setting, the MMH ICU developed a protocol utilizing regular intravenous insulin. This protocol was initiated in 2002. Monitoring of the data collected revealed effective glycemic control when this protocol was used. However, limited utilization has led to overall ineffective glycemic control in this ICU. The poor utilization is largely due to a general reluctance of physicians to start their patients on an intravenous insulin infusion. As contributing to this poor compliance is the "open" nature of the ICU. The MMH ICU is an "open" ICU, meaning that many physicians across multiple subspecialties admit to this unit. Approaches to controlling hyperglycemia vary greatly, depending largely upon the treating physician. In an attempt to improve overall glycemic control in this "open" ICU, the Subcutaneaous Insulin Aspart Hyperglycemia Protocol (SIAP) was developed which incorporates a subcutaneous insulin aspart regimen that triggers the use of a regular insulin infusion protocol when the SIAP is not adequately controlling the patient's blood glucose. This study aims to evaluate 1) the effect the SIAP on overall glycemic control in the ICU, 2) the effectiveness that the SIAP has on controlling blood glucose as compared with past practices using regular insulin, and 3) the effect the SIAP has on patient complications and outcomes in the MMH ICU.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
235 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Hyperglycemia Protocol Procedure
Primary Outcome Measure Information:
Title
1) to evaluate the effect a subcutaneous insulin aspart hyperglycemia protocol on overall glycemic control in an ICU.
Title
2) to evaluate the effect an insulin aspart hyperglycemia protocol has on controlling blood glucoses as compared with past practices of a regular insulin regimen.
Title
3) to assess the effect a hyperglycemis i9nsulin aspart protocol has on patient outcomes in this ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Valid physician order of the protocol. - Exclusion Criteria: No valid phycician order for the protocol -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Griffith
Organizational Affiliation
Moristown Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morristown Memorial hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States

12. IPD Sharing Statement

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Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

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