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Continuous Glucose Monitoring in Critically Ill Patients

NCT ID: NCT00494455

Last Updated: 2008-02-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to determine whether subcutaneous continuous glucose monitoring in critically ill patients is clinically feasible accurate and reliable.

Detailed Description

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Hyperglycemia is is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses.

Continuous glucose measurement would facilitate blood glucose control in critically ill patients. Numerous studies have shown accuracy of the subcutaneous continuous glucose monitoring derived glucose values compared to blood glucose measurements in diabetics. Studies evaluating the subcutaneous continuous glucose monitoring in an inpatient-population especially in an ICU-setting are rare. Therefore the aim of this study is the prospective evaluation of continuous subcutaneous glucose monitoring in critically ill patients with circulatory shock demanding norepinephrine therapy as compared to critically ill patients without shock.

Conditions

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Critical Illness

Keywords

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intensive insulin therapy critical illness hyperglycemia glucose monitoring shock

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Continuous subcutaneous glucose monitoring in patients without shock

Group Type ACTIVE_COMPARATOR

continuous subcutaneous glucose monitoring

Intervention Type DEVICE

continuous subcutaneous glucose monitoring for 72h

2

continuous subcutaneous glucose monitoring in patients with shock

Group Type ACTIVE_COMPARATOR

continuous subcutaneous glucose monitoring

Intervention Type DEVICE

continuous subcutaneous glucose monitoring for 72h

Interventions

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continuous subcutaneous glucose monitoring

continuous subcutaneous glucose monitoring for 72h

Intervention Type DEVICE

continuous subcutaneous glucose monitoring

continuous subcutaneous glucose monitoring for 72h

Intervention Type DEVICE

Other Intervention Names

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CGMS (Medtronic) CGMS (Medtronic)

Eligibility Criteria

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Inclusion Criteria

* Admitted patients expected to stay \>48h either with circulatory shock requiring norepinephrine therapy or without circulatory shock.

Exclusion Criteria

* Admitted patients expected to stay \<48h
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna

Principal Investigators

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Ulrike Holzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Medicine III

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Holzinger U, Warszawska J, Kitzberger R, Herkner H, Metnitz PG, Madl C. Impact of shock requiring norepinephrine on the accuracy and reliability of subcutaneous continuous glucose monitoring. Intensive Care Med. 2009 Aug;35(8):1383-9. doi: 10.1007/s00134-009-1471-y. Epub 2009 Apr 7.

Reference Type DERIVED
PMID: 19350213 (View on PubMed)

Other Identifiers

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108/2005

Identifier Type: -

Identifier Source: org_study_id