Estimating Volume Using LiDCO (EVOLVE)
|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 ]
|Study Start Date:||December 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
All subjects are included in this group, non-randomized observational study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571441
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Study Director:||DaiWai Olson, PhD RN CCRN||Duke University|