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临床试验/CTRI/2025/07/091812
CTRI/2025/07/091812尚未招募不适用

EVALUATION OF SERIAL VENOUS EXCESS ULTRASOUND SCORE(VExUS) FOR PREDICTING ONSET OF ACUTE KIDNEY INJURY IN POST- OPERATIVE PERITONITIS PATIENTS

未提供1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2025年8月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
93
试验地点
1
主要终点
To evaluate serial Venous Excess Ultrasound Score(VExUS)for predicting onset of Acute Kidney Injury in post-operative peritonitis patients.

研究概览

简要总结

This prospective observational study will be conducted after obtaining approval from the Institutional Ethics Committee. Patients meeting the inclusion and exclusion criteria will be enrolled after written informed consent is obtained from the patient or their legally authorized representative.

All enrolled patients will receive standard ICU care. At ICU admission, baseline clinical and physiological data including patient demographics, BMI, diagnosis, APACHE II score, qSOFA score, hemodynamic parameters, and vasopressor use will be recorded.

A 2D echocardiogram will be performed to exclude cardiac causes of venous congestion. Bedside ultrasound assessments will be conducted using a curvilinear probe (1–5 MHz) by an anesthesiologist with at least 3 years of ultrasound experience. Patients will be assessed in the supine position.

The Venous Excess Ultrasound Score (VExUS) will be recorded at ICU admission (0 hours) and then every 24 hours for up to 6 days or until the development of Acute Kidney Injury (AKI), whichever occurs earlier. AKI will be diagnosed and staged according to KDIGO criteria, based on changes in serum creatinine and/or urine output.

VExUS Scoring Protocol:

  1. Inferior Vena Cava (IVC) Assessment:

Measured in both long and short axes at the intrahepatic segment.

Graded based on diameter and respiratory variation:

Grade 0: <5 mm with respiratory variation

Grade I: 5–9 mm with respiratory variation

Grade II: 10–19 mm with respiratory variation

Grade III: >20 mm with respiratory variation

Grade IV: >20 mm with minimal or no respiratory variation

  1. Hepatic Vein (HV) Doppler:

Pulsed-wave Doppler of the middle or right hepatic vein.

Graded based on S and D wave morphology:

Grade 0: Normal (S > D)

Grade I: S < D with antegrade S wave

Grade III: S wave flat/inverted or biphasic trace

  1. Portal Vein (PV) Doppler:

Assessed via lateral abdominal approach.

Pulsatility Index (PI) calculated as:

Grading:

Grade 0: PI < 0.3

Grade I: PI 0.3–0.49

Grade III: PI 0.5–1.0

  1. VExUS Composite Score:

Grade 0: IVC < Grade III, HV Grade 0, PV Grade 0

Grade I: IVC Grade IV with normal HV/PV

Grade II: IVC Grade IV with mild abnormalities in HV/PV

Grade III: IVC Grade IV with severe abnormalities in HV and/or PV

In addition to VExUS, serum urea and creatinine levels will be monitored daily. The total duration of mechanical ventilation and 30-day mortality outcomes will also be recorded.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients aged 18 to 65 years with post operative peritonitis
  • ASA grade I-II 3.On USG assesment IVC diameter greater than 2cm.

排除标准

  • Expected ICU stay duration less than 24hours.
  • 2.Known Cardiac or Liver or Lung disease.
  • 3.Preexisting AKI or CKD 4.Pancreatitis.

结局指标

主要结局

To evaluate serial Venous Excess Ultrasound Score(VExUS)for predicting onset of Acute Kidney Injury in post-operative peritonitis patients.

时间窗: 0 day followed by 24 hourly till day 6 of ICU admission.

次要结局

  • 1. To correlate serial VExUS scoring with mechanical ventilation duration.(2. To correlate serial VExUS scoring with 30 day mortality.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Aman Rai

ABVIMS and Dr. Ram Manohar Lohia Hospital , New Delhi

研究点 (1)

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