A Study to Compare Carotid Doppler and Hemodynamic Parameters as Marker of Fluid Responsiveness in Undifferentiated Shock
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Analyze the predictive power of corrected carotid flow time to differentiate between fluid responders and non-responders in patients with undifferentiated shock.
研究概览
简要总结
This is a prospective, observational, cohort study which will be conducted in the critical care department at holy family hospital, New Delhi. Patient who are above the age of 18 years old, in shock, which is defined as: or mean arterial pressure <65 mmHg, decreased urine output (< 0.5ml/kg/hour), or serum lactic acid >2 mEq/L after fulfilling the eligibility criteria and the written consent process will be enrolled in the study. Baseline vital variables heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse pressure will be noted by the invasive arterial waveform trace on the MX430 Philips Intellivue patient monitor by one observer.
A second observer will do a carotid ultrasound using the linear array transducer with a frequency of 13–6 MHz of the Philips CX50 echocardiography machine.Corrected carotid artery flow time is measured.
A third observer trained in critical care ultrasound will measure Left ventricular outflow tract velocity time integral (LVOT VTI) in an apical 5 chambers cavity window with a low frequency phased array probe(1-5MHz).
Three observers will be blinded to each other’s findings to decrease the bias.
A Fluid challenge of 4ml/kg will be infused over five minutes.
Post fluid challenge all hemodynamic parameters (HR, SBP, DBP, MAP, PP) will be noted immediately after bolus immediately and two minutes post fluid challenge.
Corrected carotid flow time will be measured within 2 minutes of fluid challenge by the same observer and with the same methodology.
LVOT VTI will be measured at the previously marked sight by the same observer and previously mentioned methodology within 2 minutes of fluid challenge. Average of the three readings will be calculated.
Through the course of study, the three observers will be blinded to each other findings. To reduce inter observer variability same observer will do the repeat ultrasounds also. The maintenance fluid and further treatment will be decided as per the discretion of the treating physician.
This study aims to analyze and compare the changes in corrected carotid flow time, pulse pressure, and mean arterial pressure in response to fluid challenge in patients experiencing undifferentiated shock. By examining these hemo dynamic parameters, we hope to enhance our understanding of fluid resuscitation’s effectiveness in this critical patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age more than or equal to 18 years of age 2.Undifferentiated shock with clinical signs of shock as defined as any of the following a.
- •Mean arterial pressure less than 65 mmHg b.
- •Requiring vasopressor support to maintain mean arterial pressure more than 65mmHg c.
- •Lactate more than 2mmol per litre.
- •Oliguria defined as urine output less than 0.5ml per kg per hour e.
- •Capillary refill time more than 5 seconds.
排除标准
- •1.Moderate to severe valvular heart disease 2.Obstructive shock 3.Carotid artery stenosis 4.Poor transthoracic window 5.Isolated Cardiogenic shock 6.Not willing for consent.
结局指标
主要结局
Analyze the predictive power of corrected carotid flow time to differentiate between fluid responders and non-responders in patients with undifferentiated shock.
时间窗: Baseline 0 & at 2min after bolus
次要结局
- To compare variables like systolic blood pressure, diastolic blood(pressure, pulse pressure, mean arterial pressure as predictors of fluid resuscitation with)
研究者
Dr Sumit Ray
Holy Family Hospital