Estimating Volume Using LiDCO (EVOLVE)
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Purpose
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.
| Condition |
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Brain Injury Ischemic Stroke Hemorrhagic Stroke |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Estimating Volume Using LiDCO Versus Other Measures of Volume |
- Stroke volume variation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | December 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Primary
All subjects are included in this group, non-randomized observational study.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Neurologically injured patients
Inclusion Criteria:
- Admitted to the neurocritical care unit have an arterial line in place already connected to LiDCO monitor Physician order for monitoring intake and output
Exclusion Criteria:
- pregnant females
Contacts and Locations More Information
Publications:
| Responsible Party: | Sarah Lawless, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00571441 History of Changes |
| Other Study ID Numbers: | PRO00002786 |
| Study First Received: | December 10, 2007 |
| Last Updated: | March 15, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
stroke Brain injury nursing Critical care |
Additional relevant MeSH terms:
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Stroke Cerebral Infarction Brain Injuries Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Brain Infarction Brain Ischemia Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013