Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000513314
Ethics application status
Approved
Date submitted
17/09/2008
Date registered
2/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to evaluate the accuracy of capillary glucose measurement versus colorimetry glucose measurment as methods for determining blood glucose concentration in critically ill patients.
Scientific title
A study to evaluate the accuracy of capillary glucose measurement versus colorimetry glucose measurment as methods for determining blood glucose concentration in critically ill patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycemic control 3777 0
Condition category
Condition code
Metabolic and Endocrine 3874 3874 0 0
Metabolic disorders
Metabolic and Endocrine 3950 3950 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The objective of this study was to assess the accuracy and clinical agreement between arterial glucose concentration and capillary or central venous measures. A sole set of tests per patient was obtained from all patients in about 5 minutes. Capilary strip, arterial strip, venous and arterial laboratory dosages were performed. Arterial and central venous lines were forcefully used for the samples collection. The catheters lumen was washed with 10mL distilled water, followed by aspiration of 5mL fluids to be disposed of before the collection. Arterial and venous glucose were performed in the Olympus Au640e device, hexochinase G-6-PDHA reagent. For strip determination of glycemia blood from finger pulp lanced with a 26G needle was used. The glucometer available at the institution was the Medisense – FreeStyle Optium® (Abbott Laboratories, USA).
Intervention code [1] 3419 0
Not applicable
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4777 0
Pearson coefficient was used to determine the correlation between the different measurements of glucose levels in relation to the arterial laboratory one. This correlation analysis between methods was based on standards established by the Clinical and Laboratory Standards Institute (CLSI) that sets out that two different methods for glucose level evaluation are equivalent if Pearsons coefficient is greater than 0.9751.
Timepoint [1] 4777 0
All samples were drawn at the same time for accuracy determination. The correlation between different measurements was determined after the completion of the data collection phase, which is 3 months.
Secondary outcome [1] 8071 0
Assessment of conformity in clinical management using results provided by different methods. This was performed based on the institution protocol (Anesthesiology Department of Federal University of Sao Paulo), using the latest capillary glucose level for comparison.
Timepoint [1] 8071 0
All samples were drawn at the same time for accuracy determination. The assessment of conformity in clinical managemente using those results was performed after the completion of the data collection phase, which is 3 months.

Eligibility
Key inclusion criteria
Inclusion criteria were: age = 18 years; presence of arterial and central venous line; intensive glycemic control according to the institution’s protocol and a signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients either with diabetes or hemodynamic instability not exclusively related to sepsis were excluded

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 1201 0
Brazil
State/province [1] 1201 0

Funding & Sponsors
Funding source category [1] 3887 0
Self funded/Unfunded
Name [1] 3887 0
Country [1] 3887 0
Primary sponsor type
University
Name
Anesthesiology Deparment - Federal University of São Paulo
Address
R. Napoleão de Barros 715 5a andar Sao Paulo
Country
Brazil
Secondary sponsor category [1] 3489 0
None
Name [1] 3489 0
Address [1] 3489 0
Country [1] 3489 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5936 0
Hospital Sao Paulo
Ethics committee address [1] 5936 0
R Botucatu 572 cj 14 Sao Paulo, SP
Ethics committee country [1] 5936 0
Brazil
Date submitted for ethics approval [1] 5936 0
Approval date [1] 5936 0
06/10/2006
Ethics approval number [1] 5936 0
CEP 1416/06

Summary
Brief summary
Samples from patients with septic shock or from stable individuals without infection were collected. The correlation between measures was assessed by Pearson’s test, agreement by Bland and Altman test and accuracy by following the Clinical and Laboratory Standard Institute (CLSI) criteria, both in the global sample and in the subgroups on noradrenalin and with signs of tissue hypoperfusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28944 0
Address 28944 0
Country 28944 0
Phone 28944 0
Fax 28944 0
Email 28944 0
Contact person for public queries
Name 12101 0
Flavia Machado
Address 12101 0
R. Napoleão de Barros 715 5a andar 04024900
Country 12101 0
Brazil
Phone 12101 0
55 11 55764069
Fax 12101 0
5511 55757768
Email 12101 0
[email protected]
Contact person for scientific queries
Name 3029 0
Flavia Machado
Address 3029 0
R. Napoleão de Barros 715 5a andar 04024900 Sao Paulo
Country 3029 0
Brazil
Phone 3029 0
55 11 55764069
Fax 3029 0
Email 3029 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.