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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

Tracking Information
First Submitted Date July 29, 2016
First Posted Date August 2, 2016
Last Update Posted Date August 4, 2016
Study Start Date July 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2016)
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
Original Primary Outcome Measures
 (submitted: July 29, 2016)
fluid responsiveness [ Time Frame: after fluid challenge (30min) ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Internal Jugular Vein Distensibility to Predict Fluid Responsiveness in Patients After Cardiac Surgery
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients after cardiac surgery
Condition Cardiac Surgery
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 29, 2016)
50
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02852889
Other Study ID Numbers B2016-077
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Shanghai Zhongshan Hospital
Study Sponsor Shanghai Zhongshan Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Guo-wei Tu, PhD Fudan University
PRS Account Shanghai Zhongshan Hospital
Verification Date August 2016