Estimating Volume Using LiDCO

NCT ID: NCT00571441

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Injury Ischemic Stroke Hemorrhagic Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary

All subjects are included in this group, non-randomized observational study.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DaiWai Olson, PhD RN CCRN

Role: STUDY_DIRECTOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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. doi: 10.1186/cc2852. Epub 2004 May 5.

Reference Type BACKGROUND
PMID: 15153237 (View on PubMed)

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. doi: 10.1007/s001340051347.

Reference Type BACKGROUND
PMID: 11126264 (View on PubMed)

Other Identifiers

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Pro00002786

Identifier Type: -

Identifier Source: org_study_id

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