Internal Jugular Vein Distensibility to Predict Fluid Responsiveness in Patients After Cardiac Surgery

August 3, 2016 updated by: Shanghai Zhongshan Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
          • Zhe Luo
          • Phone Number: 3659 +86-21-64041990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients after cardiac surgery

Description

Inclusion Criteria:

  • hypotension
  • oliguria
  • high lactate level

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fluid responsiveness （mean artery pressure、cardiac output、stroke volume variation、internal jugular vein distensibility）
Time Frame: after fluid challenge (30min)
CO increased more than 10% was defined as fluid responsiveness
after fluid challenge (30min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B2016-077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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