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Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00206206
Enrollment
235
Registered
2005-09-21
Start date
2005-07-31
Completion date
Unknown
Last updated
2006-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

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.

Interventions

PROCEDUREHyperglycemia Protocol Procedure

Sponsors

Atlantic Health System
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Valid physician order of the protocol. -

Exclusion criteria

No valid phycician order for the protocol \-

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026