Estimating Volume Using LiDCO (EVOLVE)

This study has been completed.
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00571441
First received: December 10, 2007
Last updated: March 15, 2009
Last verified: March 2009
  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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: 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:
Stroke
Cerebral Infarction
Brain Injuries
Intracranial Hemorrhages
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Craniocerebral Trauma
Trauma, Nervous System
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014