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临床试验/CTRI/2025/12/098489
CTRI/2025/12/098489尚未招募不适用

Impact of combining assessment of venous congestion along with fluid responsiveness on acute kidney injury parameters in septic shock: a prospective, observational study

Dr Jai Prakash Sharma Self1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月16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
100
试验地点
1

研究概览

简要总结

This is a prospective, single-center observational study conducted in the Medical ICU at AIIMS Bhopal to evaluate whether combining venous congestion assessment using VExUS score with standard fluid responsiveness assessment can help identify impending fluid overload and prevent acute kidney injury in adults with septic shock. Approximately 100 patients aged 18 years or older with septic shock, with or without KDIGO stage 1–2 AKI, will be enrolled over 18 months. Patients with KDIGO stage 3 AKI, end-stage renal disease on dialysis, significant valvular heart disease, right-heart failure, inadequate ultrasound window, pregnancy, Child-Pugh C cirrhosis, or life expectancy less than 24 hours will be excluded. Each participant will undergo a single time-point assessment using tidal volume challenge and pulse pressure variation for fluid responsiveness, and ultrasound-based VExUS grading assessing IVC, hepatic, portal, and intrarenal Doppler. Patients will be categorized based on fluid responsiveness and congestion status; treatments received will follow routine ICU care. The primary outcome is development of AKI on day 7. Secondary outcomes include fluid overload, ICU length of stay, duration of mechanical ventilation, and 28-day mortality. Data will be collected from routine hospital records and confidentiality will be maintained.

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

  • Adults admitted to the medical ICU with septic shock with or without Acute Kidney Injury KDIGO Stage 1 or Stage 2.

排除标准

  • Known case of significant valvular heart disease • Acute Kidney Injury (KDIGO stage 3) or Acute Kidney Disease on admission • End-stage renal disease on dialysis • Child Pugh-C Cirrhosis • Pregnancy • Patients with life expectancy of less than 24 hours • Inadequate echographic window precluding ultrasound assessment • Patients with right heart failure due to any cause • Pre-existing medical renal diseases.

研究者

发起方
Dr Jai Prakash Sharma Self
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Jai Prakash Sharma

All India Institute of Medical Sciences, Bhopal

研究点 (1)

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