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Continuous Glucose Monitoring in Critically Ill Patients

Primary Purpose

Critical Illness

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

continuous subcutaneous glucose monitoring

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring, shock

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Continuous subcutaneous glucose monitoring in patients without shock

continuous subcutaneous glucose monitoring in patients with shock

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00494455

First Posted

June 27, 2007

Last Updated

February 19, 2008

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00494455

Brief Title

Continuous Glucose Monitoring in Critically Ill Patients

Official Title

Accuracy and Reliability of Continuous Glucose Monitoring in Critically Ill Patients With Shock Requiring Norepinephrine Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

Keywords

critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring, shock

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Continuous subcutaneous glucose monitoring in patients without shock

Arm Title

Arm Type

Active Comparator

Arm Description

continuous subcutaneous glucose monitoring in patients with shock

Intervention Type

Device

Intervention Name(s)

continuous subcutaneous glucose monitoring

Other Intervention Name(s)

CGMS (Medtronic)

Intervention Description

continuous subcutaneous glucose monitoring for 72h

Intervention Type

Device

Intervention Name(s)

continuous subcutaneous glucose monitoring

Other Intervention Name(s)

CGMS (Medtronic)

Intervention Description

continuous subcutaneous glucose monitoring for 72h

Primary Outcome Measure Information:

Title

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

Time Frame

72h

Secondary Outcome Measure Information:

Title

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

Time Frame

72h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrike Holzinger, MD

Organizational Affiliation

Medical University of Vienna, Department of Medicine III

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

19350213

Citation

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.

Results Reference

derived

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Continuous Glucose Monitoring in Critically Ill Patients

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