Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

• Sponsor: Atlantic Health System (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00206206
• Collaborator: (none)
• Enrollment: 235
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperglycemia	Procedure: Hyperglycemia Protocol Procedure	N/A

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart.
• Study Start Date: Jul 1, 2005

Outcome Measures

Primary Outcome Measures

1. 1) to evaluate the effect a subcutaneous insulin aspart hyperglycemia protocol on overall glycemic control in an ICU. []

2. 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. 3) to assess the effect a hyperglycemis i9nsulin aspart protocol has on patient outcomes in this ICU []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 0 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: Valid physician order of the protocol. -

Exclusion Criteria: No valid phycician order for the protocol

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Morristown Memorial hospital	Morristown	New Jersey	United States	07960

Sponsors and Collaborators

• Atlantic Health System

Investigators

• Principal Investigator: Rebecca Griffith, Moristown Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00206206
• Other Study ID Numbers: R05-04-002
• First Posted: Sep 21, 2005
• Last Update Posted: Feb 7, 2006
• Last Verified: Sep 1, 2005

• Additional relevant MeSH terms: Hyperglycemia

Study Results

No Results Posted as of Feb 7, 2006