Transhepatic Echography for Fluid Responsiveness After Cardiovascular Surgery (THEFRACS)

Performance of Static and Dynamic Accessment of Inferior Vena Cava Diameter for the Diagnosis of Fluid Responsiveness

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload; Fluid Responsiveness; Venous Congestion; Cardiovascular Surgery; Inferior Vena Cava Abnormality
• Intervention / Treatment: Diagnostic test: Echocardiography and transhepatic inferior vena cava assessment using ultrasound.

Detailed Description

Inappropriate volume expansion in the critically ill patient may leads to an increase in fluid balance, fluid overload and worse outcome. This increase in fluid balance is associated with a poor prognosis in the ICU patients, especially after cardiac surgery and high risk surgery .

Generally, the primary objective of an adequate volume expansion is a significant increase in stroke volume called fluid responsiveness (> 10% of increase). This increase in cardiac output promotes tissue perfusion, thus avoiding the occurrence of organ dysfunction.

The identification of fluid responsiveness in these patients is thus a cardinal element of haemodynamic management in intensive care. Among the non-invasive tools to assess this fluid responsiveness, the assessment of the ventilatory or forced inspiration distensibility of the inferior vena cava (IVC) has been proposed with convincing results in several clinical studies. However with various diagnostic performances and threshold.

The measurement of the diameter of the IVC is classically performed via the subcostal (SC) or subxiphoid approach. However, this approach is not always easily accessible in intensive care patients, particularly after cardiovascular surgery or laparotomy, due to practical constraints (algic scars, dressings, prone position). The transhepatic approach (TH) is a technically feasible approach in such cases. However, it has little validation in the literature, particularly in its ability to predict response to volume expansion. knowing that the correlation between the SC approach with the TH approach varies according to studies, the performance and the threshold identified for SC approach can not be translated into that of the TH approach. Further, fluid congestion status measured before IVC analyses, may be a useful confounder and safety endpoint for fluid responsiveness interpretation.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • NORD
    • Lille, NORD, France, 59000
      • Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients admitted to our intensive care unit following cardiac surgery or aortic surgery, under mechanical ventilation or not.

Description

Inclusion Criteria:

• High risk cardiovascular surgery patients admitted in ICU
• With transhepatic IVC and stroke volume measurement feasible.
• Informed consent

Exclusion Criteria:

• Righ ventricle failure
• Significant tricuspid regurgitation
• Tamponade
• Severe hypoxemia
• Age <18 ans
• No health care coverage

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Fluid responsiveness groups (responders and non-responders); Fluid responsiveness is defined as an increase in stroke volume of 10% and more form baseline.

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; Other Names: Venous congestion using ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid responsiveness	An increase in stroke volume of 10% and more, following fluid bolus of 250 to 500 ml of cristalloid or colloid.	Measurement performs before and after fluid bolus (during the 10 min following the end of fluid bolus).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous congestion	Venous congestion is defined using the VEXUS Score after sub hepatic, portal and renal veins Doppler.	during the 15 minutes following the end of the fluid bolus

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Mouhamed MOUSSA, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Inferior vena cava distensibility; Transhepatic inferior vena cava distensibility; Ultrasound diagnoses
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Edema; Hyperemia; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: 2019_17; 2019_17 2019-A02724-53 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No