NCT02852889

Brief Summary

The purpose of the study was to verify the efficacy of using internal jugular vein (IJV) size and distensibility as an index of fluid responsiveness in mechanically ventilated patients after cardiac surgery.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

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

July 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

July 29, 2016

Last Update Submit

August 3, 2016

Conditions

Cardiac Surgery

Keywords

internal jugular vein distensibility,haemodynamics

Outcome Measures

Primary Outcomes (1)

  • fluid responsiveness （mean artery pressure、cardiac output、stroke volume variation、internal jugular vein distensibility）

    CO increased more than 10% was defined as fluid responsiveness

    after fluid challenge (30min)

Study Arms (2)

fluid responders

Patients whose stroke volume index increase by \>10% in response to a 500-ml fluid bolus was defined as fluid responders.

fluid non-responders

Patients whose stroke volume index increase by \<10% in response to a 500-ml fluid bolus was defined as fluid non-responders.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients after cardiac surgery

You may qualify if:

  • hypotension
  • oliguria
  • high lactate level

You may not qualify if:

  • cardiac arrhythmia
  • clinically relevant tricuspid or mitral regurgitation, clinically relevant right heart failure
  • thrombosis in any large upper body veins
  • bilaterally inserted venous catheters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, 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
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 2, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)