Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

NCT ID: NCT00206206

Last Updated: 2006-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperglycemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Hyperglycemia Protocol Procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atlantic Health System

OTHER

Sponsor Role lead

Principal Investigators

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Rebecca Griffith

Role: PRINCIPAL_INVESTIGATOR

Moristown Memorial Hospital

Locations

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Morristown Memorial hospital

Morristown, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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R05-04-002

Identifier Type: -

Identifier Source: org_study_id