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Transhepatic Echography for Fluid Responsiveness After Cardiovascular Surgery

NCT04914455 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-12-23

No results posted yet for this study

Summary

Fluid expansion in critically ill patients following high risk surgery may induce fluid overload and worse outcome. Several tools have been developped to predict fluid responsiveness in such situation in order to avoid inappropriate fluid administration but with several limitations. Inferior vena cava (IVC) distensibility is one of those tools which has the advantage to be non-invasive, dynamic and safe, is usually measured by subcostal (SC)approach. In post surgical setting this acess is limited du to practical reasons (scar, dressing...), therefore a transhepatic (TH) approach is used but has not been validated as a fluid responsiveness prediction tool. The correlation between SC approach with the TH approach vary according to studies. Therefore the performances, the threshold identified for SC approach can not be translated to the TH approach. Further, fluid congestion status measured before IVC analyses, may be a useful confounder and safety endpoint for fluid responsiveness interpretation.

The primary objective of this study is therefore to study the performance of the IVC measured using TH approach (IVCth) in predicting of fluid responsiveness defined as an increased of 10% and over of stroke volume.

Secondary objectives intend to analyse the correlation between TH and SC approaches, to compared their performances for fluid responsiveness prediction, and to analyse the weight of venous congestion on fluid responsiveness prediction.

Conditions

  • Inferior Vena Cava Abnormality
  • Fluid Responsiveness
  • Fluid Overload
  • Venous Congestion
  • Cardiovascular Surgery

Interventions

DIAGNOSTIC_TEST

Echocardiography and transhepatic inferior vena cava assessment using ultrasound.

For all participant : * Inferior vena cava diameter will be measure before and after fluid expansion 'which administration will be decided by a physician other that the investigator). * Stroke volume using primarily VTI in TTE or a cardiac output monitoring device (Swan ganz catheter (Edwards life science), EV 1000 (edwards life science), PiCCO(Getinge)) * Absence of significant pericardial effusion of hematoma Whenever possible: Subcostal measurement of IVC, ejection fraction, cardiac outcput, mitral E, A and E' waves, TAPSE, tricupid S' wave, Right ventricle fractional area change. venous congestion assesment : hepatic vein, portal vein and renal vein Doppler to define the VEXUS Score;

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Mouhamed MOUSSA, MD · University Hospital, Lille

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2021-06-04
Completion
2021-06-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04914455 on ClinicalTrials.gov