NCT03485833

Brief Summary

The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

March 24, 2018

Last Update Submit

March 30, 2018

Conditions

Cardiac Surgery

Keywords

end-expiratory occlusion testend-inspiratory occlusion testtransesophageal echocardiographypassive legs raisingfluid challenge

Outcome Measures

Primary Outcomes (1)

  • responders

    responders are defined by volume time integral increases over 15% after volume expansion of 5ml/kg crystalloid

    within 1 minute after volume expansion

Secondary Outcomes (1)

  • nonresponders

    within 1 minute after volume expansion

Study Arms (1)

EEO and EIO test

EXPERIMENTAL

velocity time integral of the aorta measured by transesophageal echocardiography during end expiratory and end inspiratory occlusion test to predict volume responsiveness.Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

Diagnostic Test: EEO and EIO test

Interventions

EEO and EIO testDIAGNOSTIC_TEST

velocity time integral of the aorta measured by transesophageal echocardiography after end-expiratory and end-inspiratory occlusion test

EEO and EIO test

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cardiac surgical patients
  • hypotension after induction of anesthesia
  • required volume expansion by clinical judgement of the anesthesiologist

You may not qualify if:

  • younger than 18 years
  • severe valve regurgitation or systolic dysfunction of the right ventricle
  • contraindication of the transesophageal echocardiography examination
  • cardiac arrhythmia
  • left ventricular ejection fraction less than 30% before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Study Officials

  • Guo-wei Tu, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Luo, PhD

CONTACT

021-64041990luo.zhe@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2018

First Posted

April 2, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)