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临床试验/CTRI/2024/12/077674
CTRI/2024/12/077674尚未招募不适用

Correlation between the VExUS score and right atrial pressure in pediatric patients with congenital heart disease: a prospective observational study

ARMED FORCE MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年12月14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
37
试验地点
1
主要终点
To determine the correlation between the VExUS score and right atrial pressure in pediatric patients with congenital heart disease

研究概览

简要总结

1.Venous congestion is an under-recognized contributor to mortality in critically ill cardiac patients.

Unfortunately, venous congestion is difficult to measure, and right heart catheterization (RHC) has been considered the most readily available mean for measuring venous filling pressure.

2.Recently, a novel “Venous Excess Ultrasound (VExUS)”score was developed to noninvasively quantify venous congestion using inferior vena cava (IVC) diameter and Doppler flow through the hepatic, portal, and renal veins. A preliminary retrospective study of post-cardiac surgery patients in adult population showed promising results, including a high positive-likelihood ratio of high VExUS grade for acute kidney injury.

3.Our study aims to investigate and establish the relationship between the VExUS score - a measure of venous congestion obtained through ultrasound and right atrial pressure in pediatric patients with congenital heart disease.

4.Hence we aim to determine the correlation between the VExUS score and right atrial pressure in pediatric patients with congenital heart disease.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • 1.Pediatric patients diagnosed with congenital heart disease below 14 years of age 2.Patients scheduled for cardiac Cath intervention or any cardiac intervention 3.Patients or their legal guardians must provide informed consent for participation in the study.

排除标准

  • Patients aged more than 14 years.
  • Patients with coagulopathy, pre-existing sepsis, on inotropes or mechanically ventilated.
  • 2.Patients with severe hemodynamic instability or severe ventricular dysfunction that may affect the correlation between the VExUS score and right atrial pressure.
  • 3.Patients who have undergone previous cardiac surgeries to focus on the impact of the current cardiac intervention.
  • 4.Patients with primary pulmonary hypertension or severe pulmonary disease, as these conditions may independently influence right atrial pressure.
  • 5.Patients with advanced chronic kidney disease, as impaired renal function can affect fluid balance and hemodynamics.

结局指标

主要结局

To determine the correlation between the VExUS score and right atrial pressure in pediatric patients with congenital heart disease

时间窗: 1.Pre operative VExUS score grading | 15 mins before the beginning of the procedure | 2.Intraoperative RAP measurement-1minute after placement of PA catheter

次要结局

  • 1.To evaluate the predictive validity of the VExUS score in estimating right atrial pressure in the pediatric patients with congenital heart disease.(2.To explore whether there is an association between the VExUS score & postoperative clinical outcomes, such as the occurrence of complications, length of hospital stay, or the need for additional interventions in pediatric cardiac patients)

研究者

发起方
ARMED FORCE MEDICAL COLLEGE
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

SANDEEP KUMAR

ARMED FORCE MEDICAL COLLEGE

研究点 (1)

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