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临床试验/NCT06524622
NCT06524622招募中不适用

Venous Excess Ultrasound Score (VExUS) Combined With Central Venous Pressure (CVP) to Predict Clinical Outcomes in Sepsis Participants

The Second People's Hospital of Yibin1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Clinical outcomes on MAKE30

研究概览

简要总结

Introduction:

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host immune response to infection, and it is a common critical condition in the ICU. Early and timely fluid resuscitation is the cornerstone of sepsis treatment. However, excessive fluid loading can lead to interstitial edema and iatrogenic organ damage, particularly acute kidney injury (AKI). The VExUS grading system is a recently developed system that measures venous congestion through bedside ultrasound by assessing the blood flow waveforms of the portal vein, hepatic vein, and intrarenal veins, as well as the diameter of the inferior vena cava. Similarly, CVP is a commonly used indicator of venous congestion. The objective of this study is to Investigate the association between Venous Excess Ultrasound Score (VExUS), Central Venous Pressure (CVP) during the first three days of ICU admission, and the composite clinical outcome of major adverse kidney events within 30 days (MAKE 30) in sepsis participants.

Methods:

This study is a prospective, multicenter, observational study that will recruit at least 120 participants across multiple centers. Based on the definition of sepsis3.0, Participants with sepsis who are older than 18 years. Using Doppler ultrasound, Investigator will measure the IVC, HV, PV, and IRV, as well as lung ultrasound scores and cardiac-related parameters at 0-24 hours, 24-48 hours, and 48-72 hours after enrollment. Investigator will receive web-based educational courses, and image acquisition and interpretation will be adjudicated. The primary outcome is the relationship between VExUS score combined with CVP and MAKE 30 in sepsis participants.

详细描述

Study Title:

Association between VExUS Score Combined with CVP and Prediction of Clinical Outcomes in Septic participants: A Multicenter, Prospective, Observational Study.

Study Objective:

To investigate the relationship between VExUS score, CVP within the first 3 days of ICU admission in septic participants, and the composite clinical outcome of major kidney adverse events within 30 days (MAKE30).

Study Hypothesis:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult participants (age ≥ 18 years) with sepsis upon admission or during their stay in the ICU.

排除标准

  • Age < 18 years
  • Participants admitted to the ICU for < 24 hours
  • Pregnant or lactating women
  • Severe renal impairment (defined as baseline estimated glomerular filtration rate < 15 mL/min or requiring regular dialysis), including causes such as urinary tract obstruction, contrast agents, or nephrotoxic drugs
  • Liver cirrhosis with portal hypertension
  • Presence of urinary tract obstruction (which may affect IRVF waveform)
  • Inability to resolve the primary disease
  • Participants receiving palliative care
  • Inability to obtain ultrasound images
  • Inability to monitor CVP
  • Refusal of monitoring by participants or their families

结局指标

主要结局

Clinical outcomes on MAKE30

时间窗: Day 30

MAKE30 is : in-hospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine

次要结局

  • occurrence of AKI within 7 days(DAY 7)
  • length of ICU stay and in-hospital stay(DAY30)
  • VExUS score(DAY3)
  • CVP value(DAY3)
  • All-cause mortality within 30 days(DAY30)

研究者

发起方
The Second People's Hospital of Yibin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Xueqian

Resident Physician

The Second People's Hospital of Yibin

研究点 (1)

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