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临床试验/CTRI/2024/07/070495
CTRI/2024/07/070495尚未招募不适用

The role of Femoral vein Pulsatility in the prediction of Acute Kidney Injury in patients with peritonitis and Abdominal sepsis: A prospective observational study

All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年7月22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
96
试验地点
1
主要终点
Incidence of acute kidney injury

研究概览

简要总结

At the bedside, in patients with poorly accessible thoracic and abdominal wall examination after sternotomy, thoracotomy, or laparotomy; transthoracic echocardiographic (TTE) and VEXUS examinations might be challenging because of suboptimal echogenicity, due to unfavourable anatomy and sometimes, positive pressure ventilation. In such patients, the femoral vein Doppler ultrasound examination is feasible and has correlated well with venous congestion in the critically ill population. The study aims to determine the association between the presence of a pulsatile femoral vein and acute kidney injury in patients with complicated intra-abdominal infections and abdominal sepsis.

Methodology:

Baseline demographic details will be obtainedfrom medical records. The patients will be evaluated at baseline (within 24 hours of admission to ICU: Day 1 ), on Day 3( within 72 hrs of admission) and on Day 5. For each time point, the hemodynamic, respiratory and cardiac ultrasound parameters will be noted.USG examination for femoral vein pulsatility will be done by a trained intensivist with more than 5 years’ of experience in bedside ultrasound. All images will be reviewed and confirmed by another intensivist with extensive bedside ultrasound experience.

Measurement of Femoral Vein Pulsatility: Ultrasound assessment will be performed bedside in the supine position using a linear array probe. Common femoral vein will be identified 2–3 cm below the inguinal ligament and it will be examined in both short and long axis with angle correction within 60°. Normal Femoral Vein Doppler (FVD) will be defined as antegrade mildly pulsatile uninterrupted pattern with respiratory variation and retrograde flow of less than 1/3rd of antegrade flow. FVD will be considered significant or suggestive of venous congestion if either of the criteria  is fulfilled. Pulsatile in nature 2. Retrograde flow velocity of more than 10 cm/s 3. Retrograde flow velocity is more than 1/3rd of antegrade flow velocity (flow reversal)

Outcome measures: The value for baseline serum creatinine will be determined in a hierarchical approach. The lowest serum creatinine between 12 months and 24 h before hospital admission will be used when available. If no such creatinine value is available, the lowest creatinine value between 24 hours prior to hospital admission and the time of ICU admission will be used.

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

  • Adult patients, aged 18-65 years diagnosed with complicated intra-abdominal infections and abdominal sepsis (complicated intra-abdominal infections leading to sepsis and septic shock).

排除标准

  • Patients with inadequate window for USG Patients in respiratory distress (respiratory rate more than 35/min, accessory muscles of respiration in use) Patients with Liver cirrhosis Patients with Portal thrombosis Patients with Deep vein thrombosis of lower limb Pregnancy Patients with Chronic venous limb disease Patients with Chronic kidney disease Patients with AKI on admission Patients with Unilateral nephrectomy Patients who have undergone Renal transplant Patients with Unilateral or bilateral hydronephrosis Patients with Renal malignancies.

结局指标

主要结局

Incidence of acute kidney injury

时间窗: 7 days

次要结局

  • 1. Association between serial femoral vein doppler measurements (Day 1, Day 3 and Day5) and development of acute kidney injury within 7 days of admission(2. Association between serial femoral vein doppler measurements (Day 1, Day 3 and Day5) and MAKE-30 (Major Adverse Kidney Events within 30 days))

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

BHAVANA K

AIIMS New Delhi

研究点 (1)

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