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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852889
Recruitment Status : Unknown
Verified August 2016 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : August 2, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease
Cardiac Surgery

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : July 2016
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients after cardiac surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852889


Contacts
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Contact: Zhe Luo, PhD 021-64041990 ext 3659 luo.zhe@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhe Luo    +86-21-64041990 ext 3659      
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Guo-wei Tu, PhD Fudan University
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02852889    
Other Study ID Numbers: B2016-077
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shanghai Zhongshan Hospital:
internal jugular vein distensibility,haemodynamics