Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000544673
Ethics application status
Approved
Date submitted
10/09/2005
Date registered
28/09/2005
Date last updated
6/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to assess the correlation of electrolyte values in the intensive care unit: Correlation of arterial and venous blood gas analysis and formal laboratory testing
Scientific title
A study to assess the correlation of the electrolyte values in the intensive care unit: Correlation of arterial and venous blood gas analysis and formal laboratory testing
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill Patients 671 0
Condition category
Condition code
Other 745 745 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will be studied on their first routine morning bloods taken during their ICU stay. Serum electrolyte levels to be analysed will include sodium, potassium, chloride and lactate.Blood samples will be taken simultaneously as follows:
1.Arterial blood 1ml for point-of-care blood gas analysis.
2.Arterial blood 7ml for laboratory electrolyte analysis.
3.Venous blood 1ml for point-of-care blood gas analysis.
4.Venous blood 7ml for laboratory electrolyte analysis.
The timing of specimen collection will coincide with routine blood testing that occurs each morning in ICU patients, and samples 1 and 2 (above) will be those taken for routine patient assessment. Samples 3 and 4 (above) will be additional to the routine blood tests, and will be taken at the same time to ensure comparison is valid. This will involve taking an extra 8ml of blood from each participant in the study, and will occur only once for each participant. The blood samples will be taken from intravenous and arterial cannulae already in situ, and the participants will be exposed to no addition punctures, discomfort or inconvenience.
Blood electrolyte analysis will occur via two methods:
1.Blood gas analysis will be performed within the ICU by trained nursing staff. The Radiometer ABL 725 machine is located within the ICU and is maintained by the Biochemistry Department. This machine has daily quality assurance measures performed by biochemistry laboratory staff and complies with national standards for pathology testing.
2.Serum electrolyte analysis will be performed within the Biochemistry Department, in keeping with standard blood testing arrangements within The Royal Melbourne Hospital.
Intervention code [1] 453 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 932 0
The primary outcome of the study is to evaluate the agreement between electrolyte levels measured by formal laboratory serum analysis and point-of-care blood gas analysis.
Timepoint [1] 932 0
Secondary outcome [1] 1782 0
To determine the agreement between electrolyte levels measured on simultaneous arterial and venous blood samples, utilising both serum and whole blood samples.
Timepoint [1] 1782 0

Eligibility
Key inclusion criteria
The study will be conducted in the Intensive Care Unit at The Royal Melbourne Hospital and will aim to include patients who fulfil the following criteria:1. Adult patients admitted to the ICU.2. Patients who have arterial and central venous access in situ for clinical management purposes.3. Patients who consent to inclusion in the study, or if the patient is incompetent, the next-of-kin consent to patient participation in the study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/02/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 826 0
Hospital
Name [1] 826 0
Intensive care departmental Funds, Royal Melbourne Hospital
Country [1] 826 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care Unit, RMH
Address
Country
Australia
Secondary sponsor category [1] 694 0
None
Name [1] 694 0
Nil
Address [1] 694 0
Country [1] 694 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36064 0
Address 36064 0
Country 36064 0
Phone 36064 0
Fax 36064 0
Email 36064 0
Contact person for public queries
Name 9642 0
Dr M Robertson
Address 9642 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 9642 0
Australia
Phone 9642 0
+61 3 93427710
Fax 9642 0
+61 3 93428812
Email 9642 0
[email protected]
Contact person for scientific queries
Name 570 0
Belinda Howe
Address 570 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 570 0
Australia
Phone 570 0
+61 3 93427710
Fax 570 0
+61 3 93428812
Email 570 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.