NCT00206206

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

February 7, 2006

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

February 2, 2006

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

Hyperglycemia Protocol ProcedurePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morristown Memorial hospital

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rebecca Griffith

    Moristown Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2005

Last Updated

February 7, 2006

Record last verified: 2005-09

Locations

US(1)