NCT00494455

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
Last Updated

February 29, 2008

Status Verified

June 1, 2007

Enrollment Period

1 year

First QC Date

June 27, 2007

Last Update Submit

February 19, 2008

Conditions

Critical Illness

Keywords

critical illnesshyperglycemiaintensive insulin therapyglucose monitoringshock

Outcome Measures

Primary Outcomes (1)

  • correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock

    72h

Secondary Outcomes (1)

  • influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation

    72h

Study Arms (2)

1

ACTIVE COMPARATOR

Continuous subcutaneous glucose monitoring in patients without shock

Device: continuous subcutaneous glucose monitoring

2

ACTIVE COMPARATOR

continuous subcutaneous glucose monitoring in patients with shock

Device: continuous subcutaneous glucose monitoring

Interventions

continuous subcutaneous glucose monitoringDEVICE

continuous subcutaneous glucose monitoring for 72h

Also known as: CGMS (Medtronic)
1

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Admitted patients expected to stay \<48h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 19350213DERIVED

MeSH Terms

Conditions

Critical IllnessHyperglycemiaShock

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ulrike Holzinger, MD

    Medical University of Vienna, Department of Medicine III

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 29, 2007

Study Start

April 1, 2005

Primary Completion

April 1, 2006

Study Completion

March 1, 2007

Last Updated

February 29, 2008

Record last verified: 2007-06

Locations

AU(1)