NCT02292888

Brief Summary

Hypothesis: A validated technique to measure cardiac output (CO) using echocardiography is to calculate stroke volume from the product of LVOT area and LVOT VTI and multiplying the product with heart rate ( CO = SV x H/R; SV = LVOT area x LVOT VTI ). The LVOT diameter for an individual is more or less a constant measurement. Therefore using the formula mentioned above (SV = LVOT area x LVOT VTI), if the LVOT area is constant, then SV should be proportional to the VTI. This means if a PLR manoeuvre or fluid bolus helps to achieve a rise in SV, then it should be reflected in an increase in VTI as well. If this assumption is true, then an increase in the value of VTI from baseline after fluid challenge (10-15%), should identify a volume responsive patient.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

November 13, 2014

Last Update Submit

November 17, 2014

Conditions

Ischemic Heart Disease

Keywords

Doppler VTI TEE SV volume responsiveness

Outcome Measures

Primary Outcomes (1)

  • Whether a change in Doppler VTI before and after passive leg raising test (PLR) correctly reflects changes in stroke volume measured by CCO PA catheter

    the 3 highest values of VTI post PLR measured between 30 seconds to maximum of 60 seconds post PLR test are to be used and their mean value is to be compared with the mean stroke volume (SV) recorded by the CCO monitor during the same period.

    within 1 minute

Study Arms (2)

patients with LVEF >40%

ACTIVE COMPARATOR

Correlation between hemodynamic variable : SV and echocardiographic variable : Doppler VTI will be compared before and after Passive Leg Raising (PLR) test.

Other: Passive Leg Raising (PLR) test

patients with LVEF < or equal to 40%

ACTIVE COMPARATOR

Correlation between hemodynamic variable : SV and echocardiographic variable : Doppler VTI will be compared before and after Passive Leg Raising (PLR) test.

Other: Passive Leg Raising (PLR) test

Interventions

Passive Leg Raising (PLR) testOTHER

Passive Leg Raising (PLR) test

patients with LVEF < or equal to 40%patients with LVEF >40%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing CABG (coronary artery bypass surgery )

You may not qualify if:

  • Significant arrhythmias
  • Concomitant aortic aneurysms,
  • Esophageal pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 1. Reich DL Gregory W. Perioperative Transesophageal Echocardiography: A Companion to Kaplan's Cardiac Anesthesia by . Fischer 1st edition. Chapter 4.

    BACKGROUND

  • Marik PE, Monnet X, Teboul JL. Hemodynamic parameters to guide fluid therapy. Ann Intensive Care. 2011 Mar 21;1(1):1. doi: 10.1186/2110-5820-1-1.

    PMID: 21906322RESULT

  • Cavallaro F, Sandroni C, Marano C, La Torre G, Mannocci A, De Waure C, Bello G, Maviglia R, Antonelli M. Diagnostic accuracy of passive leg raising for prediction of fluid responsiveness in adults: systematic review and meta-analysis of clinical studies. Intensive Care Med. 2010 Sep;36(9):1475-83. doi: 10.1007/s00134-010-1929-y. Epub 2010 May 26.

    PMID: 20502865RESULT

  • Atherton JJ. Screening for left ventricular systolic dysfunction: is imaging a solution? JACC Cardiovasc Imaging. 2010 Apr;3(4):421-8. doi: 10.1016/j.jcmg.2009.11.014.

    PMID: 20394904RESULT

  • Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.

    PMID: 16540963RESULT

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiac Anesthesiologist & Intensivist

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 17, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Last Updated

November 18, 2014

Record last verified: 2014-11