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临床试验/CTRI/2025/07/090007
CTRI/2025/07/090007尚未招募不适用

Evaluation of Vena Cava Ultrasound for Predicting Venous Congestion in Critically Ill Patients: A Prospective Observational Study

SELF1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
SELF
入组人数
64
试验地点
1
主要终点
The primary outcome of interest is venous congestion defined as presence of mild congestion in atleast one of the hepatic portal and renal doppler assessments

研究概览

简要总结

This prospective observational study aims to evaluate the utility of vena cava ultrasound in predicting systemic venous congestion in critically ill invasively ventilated patients admitted to a mixed medical-surgical ICU Traditional markers like central venous pressure have limitations and while the VEXUS (Venous Excess Ultrasound) grading system has shown promise in cardiac surgical patients its applicability in non-cardiac ICU patients remains unclear

The primary objective is to assess the predictive ability of the maximum anteroposterior diameter of the inferior vena cava (IVCAP) for venous congestion, defined by at least mild abnormalities in hepatic portal or renal venous Doppler

Secondary objectives include comparing diagnostic accuracy between IVCAP lateral diameter IVCLat their ratio IVCAP Lat and IVC distensibility index along with evaluating their correlation with acute kidney injury AKI

Adult patients m ore than18 years expected to remain ventilated for more than 48 hours will undergo serial ultrasound evaluations over 5 days Venous Doppler studies and IVC measurements will be performed with standardized protocols using B-mode and Doppler imaging  AKI will be assessed as per KDIGO criteria and correlated with ultrasound findings using logistic regression and ROC analysis

The study will enroll 64 patients as determined by sample size calculations based on expected AUC values Results aim to establish optimal IVC diameter cutoffs and validate vena cava ultrasound as a non-invasive diagnostic tool for venous congestion and its association with AKI in the ICU setting

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged 18 years or older who are admitted to the ICU invasively ventilated and expected to stay for at least 48 hours will be eligible for inclusion.

排除标准

  • Patients will be excluded if they are pregnant have known anatomical anomalies or obstruction of the IVC present with unreliable IVC windows on ultrasound liver cirrhosis or if consent is refused.

结局指标

主要结局

The primary outcome of interest is venous congestion defined as presence of mild congestion in atleast one of the hepatic portal and renal doppler assessments

时间窗: 5days

次要结局

  • The primary outcome of interest is venous congestion defined as presence of mild congestion in atleast one of the hepatic, portal and renal doppler assessments.(5days)

研究者

发起方
SELF
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Lutfur rahman

AIIMS Guwahati

研究点 (1)

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