Estimating Volume Using LiDCO (EVOLVE)
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|ClinicalTrials.gov Identifier: NCT00571441|
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : January 21, 2016
|Condition or disease|
|Brain Injury Ischemic Stroke Hemorrhagic Stroke|
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 Type :||Observational|
|Actual Enrollment :||34 participants|
|Observational Model:||Case Control|
|Official Title:||Estimating Volume Using LiDCO Versus Other Measures of Volume|
|Study Start Date :||December 2007|
|Primary Completion Date :||September 2008|
|Study Completion Date :||December 2008|
All subjects are included in this group, non-randomized observational study.
- Stroke volume variation [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571441
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Study Director:||DaiWai Olson, PhD RN CCRN||Duke University|