Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

Hyperglycemia Clinical Trial

Official title:

Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00206206
• Other study ID #: R05-04-002
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: February 2, 2006
• Start date: July 2005

Study information

• Verified date: September 2005
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 235
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Valid physician order of the protocol. -

Exclusion Criteria: No valid phycician order for the protocol

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Procedure:
• Hyperglycemia Protocol Procedure

Locations

Country	Name	City	State
United States	Morristown Memorial hospital	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) to evaluate the effect a subcutaneous insulin aspart hyperglycemia protocol on overall glycemic control in an ICU.
Primary	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.
Primary	3) to assess the effect a hyperglycemis i9nsulin aspart protocol has on patient outcomes in this ICU