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Sponsored by: |
Atlantic Health System |
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Information provided by: | Atlantic Health System |
ClinicalTrials.gov Identifier: | NCT00206206 |
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 |
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Hyperglycemia |
Procedure: Hyperglycemia Protocol Procedure |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart. |
Estimated Enrollment: | 235 |
Study Start Date: | July 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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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United States, New Jersey | |
Morristown Memorial hospital | |
Morristown, New Jersey, United States, 07960 |
Principal Investigator: | Rebecca Griffith | Moristown Memorial Hospital |
Study ID Numbers: | R05-04-002 |
Study First Received: | September 13, 2005 |
Last Updated: | February 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00206206 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hypoglycemic Agents Metabolic Diseases Hyperglycemia Insulin, Asp(B28)- |
Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Hyperglycemia Physiological Effects of Drugs |
Insulin, Asp(B28)- Glucose Metabolism Disorders Pharmacologic Actions |