Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

This study has been terminated.
Sponsor:
Information provided by:
Atlantic Health System
ClinicalTrials.gov Identifier:
NCT00206206
First received: September 13, 2005
Last updated: February 2, 2006
Last verified: September 2005
  Purpose

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 Intervention
Hyperglycemia
Procedure: Hyperglycemia Protocol Procedure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart.

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

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

Estimated Enrollment: 235
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Valid physician order of the protocol. -

Exclusion Criteria: No valid phycician order for the protocol

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00206206

Locations
United States, New Jersey
Morristown Memorial hospital
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
Investigators
Principal Investigator: Rebecca Griffith Moristown Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00206206     History of Changes
Other Study ID Numbers: R05-04-002
Study First Received: September 13, 2005
Last Updated: February 2, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014