Estimating Volume Using LiDCO

Ischemic Stroke Clinical Trial

— EVOLVE  

Official title:

Estimating Volume Using LiDCO Versus Other Measures of Volume

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571441
• Other study ID #: Pro00002786
• Status: Completed
• Phase: N/A
• First received: December 10, 2007
• Last updated: January 20, 2016
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Linton RA, Jonas MM, Tibby SM, Murdoch IA, O'Brien TK, Linton NW, Band DM. Cardiac output measured by lithium dilution and transpulmonary thermodilution in patients in a paediatric intensive care unit. Intensive Care Med. 2000 Oct;26(10):1507-11. — View Citation

Pearse RM, Ikram K, Barry J. Equipment review: an appraisal of the LiDCO plus method of measuring cardiac output. Crit Care. 2004 Jun;8(3):190-5. Epub 2004 May 5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke volume variation		24 hours	No