Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

Not Applicable

Terminated

• Conditions: Hyperglycemia

• Registration Number: NCT00206206
• Lead Sponsor: Atlantic Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Submitted: 2006-02-02
• Last Update Posted: 2006-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

Valid physician order of the protocol. -

Exclusion Criteria

No valid phycician order for the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Morristown Memorial hospital; 🇺🇸 Morristown, New Jersey, United States