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临床试验/CTRI/2025/11/097774
CTRI/2025/11/097774尚未招募不适用

CORRELATION OF INDIVIDUAL COMPONENTS AND OF OVERALL VExUS SCORE WITH ECHOCARDIOGRAPHIC PARAMETERS OF RIGHT HEART DIMENSIONS AND FUNCTIONS IN ADULTS UNDERGOING CARDIAC VALVULAR SURGERY : A PROSPECTIVE OBSERVATIONAL STUDY

Post Graduate Institiute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
157
试验地点
1
主要终点
To evaluate the correlation between individual components of the Venous Excess Ultrasound (VExUS) score, as well as the composite VExUS score, with echocardiographic parameters reflecting right heart dimensions and function.

研究概览

简要总结

The primary purpose of this research protocol is to evaluate the relationship between the Venous Excess Ultrasound VExUS score a comprehensive point of care ultrasound method for assessing systemic venous congestion and echocardiographic measures of right heart structure and function in adult patients undergoing cardiac valvular surgery This prospective observational study arises from the knowledge that traditional means of evaluating congestion such as physical examination and isolated inferior vena cava IVC assessment are often subjective inconsistent and influenced by technical and physiologic variables As right ventricular RV function and venous congestion have broad implications for outcomes in cardiac surgery the study aims to provide a more objective and reliable correlation using an integrated ultrasound approach with the VExUS score

Rationale and Background

Venous congestion is a key determinant of morbidity following cardiac surgery frequently driven by RV dysfunction and assessment by standard right heart catheterization is invasive and not always feasible The VExUS score combining IVC hepatic vein portal vein and renal vein Doppler ultrasonography offers a realtime noninvasive alternative to gauge venous congestion with greater accuracy Understanding the precise relationship between VExUS and echocardiographic surrogates of RV function such as TAPSE tricuspid annular plane systolic excursion RV fractional area change FAC and RV systolic pressure RVSP can improve patient risk stratification fluid management and outcome prediction in perioperative care

The protocol specifically seeks to

Quantify the correlation between the grades and severity of each VExUS component hepatic portal and renal vein Doppler patterns and overall VExUS score against established echocardiographic parameters reflecting right heart dimensions like RV basal diameter RA area and function TAPSE RV FAC RV systolic pressure Identify which single VExUS component most strongly mirrors the severity and nature of right heart impairment Determine whether preoperative VExUS measurements offer incremental predictive value for perioperative morbidity including acute kidney injury liver dysfunction mechanical ventilation need ICU stay and mortality beyond established surgical risk scores such as EuroSCORE II and STS score

Study Hypothesis

The study hypothesizes that noninvasive assessment of systemic venous congestion using VExUS will demonstrate a strong positive correlation with echocardiographic parameters reflecting right ventricular function particularly with indices such as TAPSE and RV FAC It further posits that higher VExUS scores and severity grades will be associated with worse RV function on echocardiography and that this relationship will help guide management decisions and outcome prediction in the perioperative cardiac surgical population

By systematically exploring these relationships the study aims to validate the utility of VExUS scoring in the cardiac anesthesia critical care domain and guide best practices for fluid and congestion management of vulnerable patients undergoing complex valvular surgeries

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • undergoing cardiac valvular surgery.

排除标准

  • 1.Declined consent 2.Surgery of congenital heart disease 3.Poor transthoracic window 4.Pericardial disease 5.Existing tricuspid ring/prosthesis 6.Patient on renal replacement therapy.

结局指标

主要结局

To evaluate the correlation between individual components of the Venous Excess Ultrasound (VExUS) score, as well as the composite VExUS score, with echocardiographic parameters reflecting right heart dimensions and function.

时间窗: Prior to anaesthesia induction in operating room

次要结局

  • 1. To identify the VExUS score component that demonstrates the strongest correlation with echocardiographic indicators of right heart size and function.(Prior to anaesthesia induction in operating room)
  • To assess the incremental predictive value of the preoperative VExUS score in estimating short-term perioperative morbidity and mortality following cardiac valvular surgery.

研究者

发起方
Post Graduate Institiute of Medical Education and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vendra S R

PGIMER

研究点 (1)

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