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临床试验/CTRI/2024/10/075067
CTRI/2024/10/075067尚未招募2 期

To compare Aorto-Caval Index versus IVC Collapsibility Index in assessing fluid responsiveness in patients presenting with Septic Shock to Emergency Department – A Pilot Randomized Controlled Trial

Dr Harikrishnan S1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月21日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To compare Aorto-Caval Index versus IVC Collapsibility Index in assessing fluid

研究概览

简要总结

This study is a prospective, randomized controlled, single-centre, trial comparing Aorto-Caval Index versus IVC Collapsibility Index in assessing fluid responsiveness in patients presenting with Septic Shock to Emergency Department. in 100 patients who are presenting to the Emergency Department in Septic Shock that will be conducted in All India Institute of Medical Sciences, New Delhi.

The primary outcome is to compare Aorto-Caval Index versus IVC Collapsibility Index in assessing fluid responsiveness in patients presenting with Septic Shock to Emergency Department.

The secondary outcome is to assess the effect of Passive Leg Raising (PLR) on Aorto-caval index and Inferior Vena Cava (IVC) Collapsibility Index, to check the feasibility of incorporating Aorto-Caval Index in RUSH protocol for baseline fluid status and dynamic fluid resuscitation and to compare the difference between Aorto-caval index obtained from subxiphoid and transhepatic right coronal views.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients presenting to the Emergency Department in Septic Shock (Systolic BP less than 90mmHg or Shock Index more than 1) as screened using NEWS score more than or equal to
  • Age greater than or equal to 18 years Valid consent given by the patient or Legally Accepted Representative (LAR).

排除标准

  • Patients less than 18 years of age Patients presenting in Cardiac Arrest.
  • Patients with ascites, increased intra-abdominal pressure or intra-abdominal pathologies like space occupying lesions.
  • Pregnant women Intubated patients on mechanical ventilation support.

结局指标

主要结局

To compare Aorto-Caval Index versus IVC Collapsibility Index in assessing fluid

时间窗: at baseline, 30 minutes

responsiveness in patients presenting with Septic Shock to Emergency Department.

时间窗: at baseline, 30 minutes

次要结局

  • To assess the effect of Passive Leg Raising (PLR) on Aorto-caval index & Inferior(Vena Cava (IVC) Collapsibility Index.)
  • To check the feasibility of incorporating Aorto-Caval Index in RUSH protocol for(baseline fluid status & dynamic fluid resuscitation.)
  • To compare the difference between Aorto-caval index obtained from subxiphoid &(transhepatic right coronal views.)

研究者

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

Dr Harikrishnan S

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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