Transhepatic Echography for Fluid Responsiveness After Cardiovascular Surgery

NCT04914455 | Completed

• 2 other identifiers: 2019_172019_17 2019-A02724-53
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Inferior vena cava distensibility; Transhepatic inferior vena cava distensibility; Ultrasound diagnoses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Venous congestion

  during the 15 minutes following the end of the fluid bolus

Study Arms (1)

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.

Interventions

Echocardiography and transhepatic inferior vena cava assessment using ultrasound. DIAGNOSTIC_TEST

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;

Also known as: Venous congestion using ultrasound

Fluid responsiveness groups (responders and non-responders)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille

Lille, NORD, 59000, France

Location

MeSH Terms

Conditions

Edema; Hyperemia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Mouhamed MOUSSA, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 4, 2021
• Study Start: December 8, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)