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Estimating Volume Using LiDCO (EVOLVE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00571441
First Posted: December 12, 2007
Last Update Posted: January 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  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
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

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Stroke volume variation [ Time Frame: 24 hours ]

Enrollment: 34
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
Primary
All subjects are included in this group, non-randomized observational study.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurologically injured patients
Criteria

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
Information from the National Library of Medicine

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


Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Study Director: DaiWai Olson, PhD RN CCRN Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00571441     History of Changes
Other Study ID Numbers: Pro00002786
First Submitted: December 10, 2007
First Posted: December 12, 2007
Last Update Posted: January 21, 2016
Last Verified: March 2009

Keywords provided by Duke University:
stroke
Brain injury
nursing
Critical care

Additional relevant MeSH terms:
Stroke
Brain Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries