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Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT00571441
Study type Observational
Source Duke University
Contact
Status Completed
Phase N/A
Start date December 2007
Completion date December 2008

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