Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000128099
Ethics application status
Approved
Date submitted
24/01/2010
Date registered
9/02/2010
Date last updated
9/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of lactate values obtained from different sites and its clinical significance in patients with severe sepsis: an observational study
Scientific title
Comparison of lactate values obtained from different sites and its clinical significance in patients with severe sepsis: an observational study
Secondary ID [1] 1376 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perfusion in sepsis 256663 0
Condition category
Condition code
Metabolic and Endocrine 256823 256823 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with a central venous access and health volunteers as a control group were prospectively assessed. Blood was drawn simultaneously for measurements of Lart, Lper and Lcen with the first sample collected within 24h after onset of organ dysfunction. A blinded intensivist stated clinical intervention based on each of the lactate values obtained. Results were analyzed using Pearson correlation, Bland-Altman and McNemar tests and considered significant if p=0.05. Overall duration of this study: 6 months
Intervention code [1] 255897 0
Not applicable
Comparator / control treatment
arterial lactate, regarding comparisons with venous and central venous lactate

health voluntears in comparison with septic patients, regarding behavior of this sites of collection potencial differences
Control group
Active

Outcomes
Primary outcome [1] 257685 0
Comparison of lactate values. Pearson?s correlations will be calculated using arterial lactate as a reference for comparison both with central venous lactate and peripheral lactete. The results will be expressed through the correlation coefficient (R) and the descriptive level (p) to test its significance. Additionally, the Bland and Altman test will be used to determine the bias and the limits of agreement between central venous and peripheral lactate compared with the reference value (arterial). The results of Bland Altman test will be expressed in bias ? standard deviation (confidence interval 95%), with this confidence interval representing the limits of agreement.
Timepoint [1] 257685 0
measured after 6 months of the study
Secondary outcome [1] 263030 0
nil
Timepoint [1] 263030 0
nil

Eligibility
Key inclusion criteria
This is a cross-sectional study involving patients admitted at the intensive care unit of a tertiary university hospital who were diagnosed with severe sepsis and septic shock, according to the definitions of the 1992 American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) consensus.16 Organ dysfunction should be acutely associated with the sepsis episode Patients could be included if they met the following inclusion criteria: onset of organ dysfunction within less than 24 hours of the first sample collection, indication for or presence of a central venous catheter, signature of an informed consent term by the patient or his/her legal representative and age over 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were the presence of chronic or acute hepatic failure and the need for dialysis.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
81
Accrual to date
Final
Recruitment outside Australia
Country [1] 2434 0
Brazil
State/province [1] 2434 0

Funding & Sponsors
Funding source category [1] 256385 0
University
Name [1] 256385 0
Universidade Federal de Sao Paulo
Country [1] 256385 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Sao Paulo
Address
Universidade Federal de Sao Paulo
R, Napoleao de Barros 715 5a andar
04024900 Sao Paulo - SP
Country
Brazil
Secondary sponsor category [1] 251700 0
None
Name [1] 251700 0
Address [1] 251700 0
Country [1] 251700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258454 0
Comite de Etica em Pesquisa Universidade Federal de Sao Paulo (UNIFESP)
Ethics committee address [1] 258454 0
Ethics committee country [1] 258454 0
Brazil
Date submitted for ethics approval [1] 258454 0
Approval date [1] 258454 0
17/02/2005
Ethics approval number [1] 258454 0

Summary
Brief summary
Blood will be drawn simultaneously for measurements of Lart, Lper and Lcen, every 12 hours, with a maximum of 3 collections per patient. For collection of Lart, 1mL of blood will be obtained through arterial puncture or from an arterial line. A tourniquet will be used in the upper limb for up to 2 minutes and 1mL of peripheral venous blood will be obtained for Lper determination. Lcen will be obtained through the collection of 1mL of blood from a central venous catheter placed in subclavian or internal jugular vein. To analyze the concordance in medical management a boarded-certified intensivist, blinded to the site of blood collection, will define the management in face of each sample, following the unit protocol that was based on Surviving Sepsis Campaign resuscitation bundle.The correlation and agreement between the lactate values were analyzed in subgroups of patients according to the presence of respiratory dysfunction, septic shock and central venous oxygen saturation.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30760 0
Address 30760 0
Country 30760 0
Phone 30760 0
Fax 30760 0
Email 30760 0
Contact person for public queries
Name 14007 0
Flavia R Machado
Address 14007 0
Napoleao de Barros 715 5a andar
Sao Paulo SP
Country 14007 0
Brazil
Phone 14007 0
55 11 - 55764069
Fax 14007 0
Email 14007 0
fmachado.dcir@epm.br
Contact person for scientific queries
Name 4935 0
Flavia R Machado
Address 4935 0
Napoleao de Barros 715 5a andar
Sao Paulo SP
Country 4935 0
Brazil
Phone 4935 0
55 11 - 55764069
Fax 4935 0
Email 4935 0
fmachado.dcir@epm.br

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
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Documents added automatically
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