Transhepatic Echography for Fluid Responsiveness After Cardiovascular Surgery

Fluid Overload Clinical Trial

— THEFRACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914455
• Other study ID #: 2019_17
• Secondary ID: 2019_17 2019-A02
• Status: Recruiting
• Start date: December 8, 2020
• Est. completion date: July 28, 2023

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: Mouhamed D. D MOUSSA, MD
• Phone: 0320445962
• Email: mouhamed.moussa[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: July 28, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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;

Locations

Country	Name	City	State
France	Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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