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临床试验/CTRI/2025/07/091519
CTRI/2025/07/091519尚未招募不适用

Assessment of fluid responsiveness by analyzing stroke volume change with Transthoracic echocardiography on passive leg raising test in hemodynamically unstable patients

Dr Harsh Kumar1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2026年8月1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
93
试验地点
1
主要终点
Compare changes in Stroke Volume

研究概览

简要总结

Hemodynamic instability in critically ill patients often prompts fluid resuscitation, yet overzealous fluid administration risks pulmonary edema, intracranial hypertension, and cardiac overload. Traditional static measures like CVP and PAOP poorly predict whether a patient’s cardiac output will actually improve after fluids, whereas dynamic assessments like stroke volume variation, pulse pressure variation, and especially passive leg raising offer greater sensitivity and specificity. PLR transiently increases preload by shifting venous blood centrally, acting as a reversible, noninvasive self-fluid challenge, and a 10 to 15 percent rise in stroke volume during PLR reliably identifies fluid responders. Transthoracic echocardiography, by measuring LVOT velocity time integral before and after PLR and combining SV changes with cardiac index and IVC collapsibility provides real time,risk free evaluation of fluid responsiveness. This study hypothesizes that PLR induced SV changes measured by TTE can accurately predict which hemodynamically unstable patients will benefit from fluid administration

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

  • Patients or Relatives willing to give consent, Hemodynamically unstable patients, Mean arterial pressure less than 65 mmHg, need for any vasopressor or ionotropic support, blood lactate levels more than 2 mmol per litre, urine output less than 0.5mlper kg per hr for more than 2hr, tachycardia more than 100 bpm, Signs of hypoperfusion.

排除标准

  • Poor cardiac echogenicity, Cardiac arrythmias at the time of study, Aortic valve disease, Contraindications of PLR (Intracranial hypertension, Intra-abdominal hypertension), Venous stasis (DVT),.

结局指标

主要结局

Compare changes in Stroke Volume

时间窗: baseline, 15 minutes

in response to fluid challenge and passive leg raising

时间窗: baseline, 15 minutes

次要结局

  • Measure & compare percentage changes in mean value, in response to the PLR test & FC test in mean arterial pressure(baseline , 15 minutes)
  • Measure & compare percentage changes in mean value, in response to the PLR test & FC test in ejection fraction(baseline , 15 minutes)
  • Measure & compare percentage changes in mean value, in response to the PLR test & FC test in heart rate(baseline , 15 minutes)
  • Measure & compare percentage changes in mean value, in response to the PLR test & FC test in IVC diameter(baseline , 15 minutes)
  • Measure & compare percentage changes in mean value, in response to the PLR test & FC test in Cardiac Index(baseline , 15 minutes)

研究者

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

Dr Harsh Kumar

ESIC Hospital And PGIMSR

研究点 (1)

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