Electrolyte ValuesNCT00256061
Assessment of Electrolyte Values in the Intensive Care Unit:Comparison Between Arterial and Venous Blood Gas Analysis and Formal Laboratory Testing
An observational study of Electrolyte Values, run by Melbourne Health.
Trial summary
The study hypothesis is that in critically ill patients there is significant differences between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrolyte Values
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Feb 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 years or older admitted to the intensive care unit
- Patients who have arterial and central venous access insitu for clinical management purposes.
- Patients who consent to inclusion in the study, or if the patient is not competent, the next of kins' consent.
Who cannot join
- Nil-
About this study
The study hypothesis is that in critically ill patients there is significant differences between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples.
Read the detailed description
The sudy hypothesis is that in critically ill patients there is a significant difference between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples.
The study aim is determine the agreement between electrolyte levels measure by formal laboratory serum analysis and point-of-care blood gas analysis.
Also, to determine the agreement between electrolyte levels measured on simultaneous arterial and venous blood samples, using both serum and whole blood samples.
- Conditions
- Electrolyte Values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startFeb 2003
- Study completionFeb 2004
Why it stopped: Due to the publication of significant literature in this area since commencement of the project which has now rendered the project unnecessary.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrolyte ValuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Investigators
- Megan Robertson, MBBS, Principal investigator, Royal Melbourne Hospital, Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256061
- Sponsor's protocol ID
- 2002.229
- Status last verified
- Apr 2015
- First submitted
- 17 Nov 2005
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Electrolyte Values in the Intensive Care Unit:Comparison Between Arterial and Venous Blood Gas Analysis and Formal Laboratory Testing
- ClinicalTrials.gov ID
- NCT00256061
- Acronym / sponsor ID
- 2002.229
- Conditions
- Electrolyte Values
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to the publication of significant literature in this area since commencement of the project which has now rendered the project unnecessary.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Feb 2004
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study hypothesis is that in critically ill patients there is significant differences between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples.
Detailed description
The sudy hypothesis is that in critically ill patients there is a significant difference between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples.
The study aim is determine the agreement between electrolyte levels measure by formal laboratory serum analysis and point-of-care blood gas analysis.
Also, to determine the agreement between electrolyte levels measured on simultaneous arterial and venous blood samples, using both serum and whole blood samples.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients 18 years or older admitted to the intensive care unit
- Patients who have arterial and central venous access insitu for clinical management purposes.
- Patients who consent to inclusion in the study, or if the patient is not competent, the next of kins' consent.
Key exclusion criteria (1 listed)
- Nil-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Robertson, MBBS principal investigator
Royal Melbourne Hospital, Intensive Care Unit
Questions about this trial
What is this clinical trial studying?
An observational study of Electrolyte Values, run by Melbourne Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.