Brain InjuryEVOLVENCT00571441
Estimating Volume Using LiDCO
An observational study of Brain Injury and Ischemic Stroke, run by Duke University at 1 site in United States.
Trial summary
We hypothesize that the stroke volume variation measured using the commercially available LiDCO monitor provides a reasonable estimate of volume when compared to standard measures. This study will collate data that is already being collected by the bedside nurses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Ischemic Stroke, Hemorrhagic Stroke
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2008
- 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
Study population: Neurologically injured patients
Who may be able to join
- Admitted to the neurocritical care unit have an arterial line in place already connected to LiDCO monitor Physician order for monitoring intake and output
Who cannot join
- pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimating Volume Using LiDCO Versus Other Measures of Volume
We hypothesize that the stroke volume variation measured using the commercially available LiDCO monitor provides a reasonable estimate of volume when compared to standard measures. This study will collate data that is already being collected by the bedside nurses.
Read the detailed description
Objective: To compare measurement of stroke volume variance with intake/output measurements, weight, BUN/Creatnine values, and central venous pressure.
Design: Non-experimental, non-randomized observational comparative study.
Setting: The sixteen bed Neurocritical Care Unit at Duke University Hospital.
Patients: 45 adult (over 18 years) subjects with intracranial pathology who require volume resuscitation. Only patients with current LiDCO monitoring will be considered eligible for inclusion in the study.
Interventions: This is an observational study. Subjects will receive standard-of-care treatment without additional intervention.
Data Analysis: All data will be collected by the principal investigator / study coordinator. Personal patient information will be removed (deidentified) from the permanent data collection records to protect patient confidentiality. Data collected will be entered into a Microsoft Excel electronic spreadsheet and will be saved on a USB Disk drive to be stored in a locked cabinet in the investigator's office. Statistical analysis using SAS v9.1, (Cary, NC) will be conducted with a level of significance set at .05 (alpha) using standardized comparative analysis techniques.
- Conditions
- Brain Injury, Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- stroke, Brain injury, nursing, Critical care
- Medical subject headings
- Brain Injuries, Ischemic Stroke, Hemorrhagic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary | All subjects are included in this group, non-randomized observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume variation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DaiWai Olson, PhD RN CCRN, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571441
- Sponsor's protocol ID
- Pro00002786
- Acronym
- EVOLVE
- Status last verified
- Mar 2009
- First submitted
- 10 Dec 2007
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pearse RM, Ikram K, Barry J. Equipment review: an appraisal of the LiDCO plus method of measuring cardiac output. Crit Care. 2004 Jun;8(3):190-5. doi: 10.1186/cc2852. Epub 2004 May 5.
PubMed 15153237Linton RA, Jonas MM, Tibby SM, Murdoch IA, O'Brien TK, Linton NW, Band DM. Cardiac output measured by lithium dilution and transpulmonary thermodilution in patients in a paediatric intensive care unit. Intensive Care Med. 2000 Oct;26(10):1507-11. doi: 10.1007/s001340051347.
PubMed 11126264
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating Volume Using LiDCO Versus Other Measures of Volume
- ClinicalTrials.gov ID
- NCT00571441
- Acronym / sponsor ID
- EVOLVE / Pro00002786
- Conditions
- Brain Injury, Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- stroke, Brain injury, nursing, Critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Dec 2007 (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.
We hypothesize that the stroke volume variation measured using the commercially available LiDCO monitor provides a reasonable estimate of volume when compared to standard measures. This study will collate data that is already being collected by the bedside nurses.
Detailed description
Objective: To compare measurement of stroke volume variance with intake/output measurements, weight, BUN/Creatnine values, and central venous pressure.
Design: Non-experimental, non-randomized observational comparative study.
Setting: The sixteen bed Neurocritical Care Unit at Duke University Hospital.
Patients: 45 adult (over 18 years) subjects with intracranial pathology who require volume resuscitation. Only patients with current LiDCO monitoring will be considered eligible for inclusion in the study.
Interventions: This is an observational study. Subjects will receive standard-of-care treatment without additional intervention.
Data Analysis: All data will be collected by the principal investigator / study coordinator. Personal patient information will be removed (deidentified) from the permanent data collection records to protect patient confidentiality. Data collected will be entered into a Microsoft Excel electronic spreadsheet and will be saved on a USB Disk drive to be stored in a locked cabinet in the investigator's office. Statistical analysis using SAS v9.1, (Cary, NC) will be conducted with a level of significance set at .05 (alpha) using standardized comparative analysis techniques.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | – | –All subjects are included in this group, non-randomized observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurologically injured patients
Key inclusion criteria (1 listed)
- Admitted to the neurocritical care unit have an arterial line in place already connected to LiDCO monitor Physician order for monitoring intake and output
Key exclusion criteria (1 listed)
- pregnant females
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
Stroke volume variation
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Background: PubMed 15153237Pearse RM, Ikram K, Barry J. Equipment review: an appraisal of the LiDCO plus method of measuring cardiac output. Crit Care. 2004 Jun;8(3):190-5. doi: 10.1186/cc2852. Epub 2004 May 5.
- Background: PubMed 11126264Linton RA, Jonas MM, Tibby SM, Murdoch IA, O'Brien TK, Linton NW, Band DM. Cardiac output measured by lithium dilution and transpulmonary thermodilution in patients in a paediatric intensive care unit. Intensive Care Med. 2000 Oct;26(10):1507-11. doi: 10.1007/s001340051347.
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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.
DaiWai Olson, PhD RN CCRN study director
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Ischemic Stroke, run by Duke University at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Stroke volume variation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571441, which also lists 2 linked publications.
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 21 Jan 2016.