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临床试验/NCT06390423
NCT06390423招募中不适用

Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates Such as Pulse Pressure Variation (PPV), End-tidal CO2 (Carbon Dioxide), Bioreactance (Stroke Volume Index -SVI) and Velocity Time Integral on Echocardiographic Exam for Fluid Responsiveness in Patients With Moderately Severe ARDS (Acute Respiratory Distress Syndrome)

CentraCare1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
CentraCare
入组人数
64
试验地点
1
主要终点
Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min

研究概览

简要总结

In the critically ill population, fluid administration in an unstable patient is perhaps the most common intervention that is performed. Uncorrected hypovolemia with inappropriate vasopressors lead to organ hypoperfusion where as overzealous fluid administration especially in ARDS (Adult respiratory distress syndrome) can increase mortality. It has been estimated that only 50% of hemodynamically unstable critically ill patients are volume responsive, hence dynamic assessment of preload responsiveness has been proposed to better identify those individuals who would benefit from fluid bolus.

详细描述

Fluid responsiveness in patients with moderate to severe ARDS is crucial, as additional unnecessary fluid may be harmful. Various techniques of hemodynamic assessment exist, each with its own advantages and limitations. This study compares different techniques of preload responsiveness that include passive leg raise (PLR) and mini-fluid challenge induced changes in Pulse pressure variation (PPV), End tidal CO2, Bioreactance based Stroke volume index (SVI) and velocity time integral (VTI) on Echocardiogram.

Study protocol :

Baseline Echo with VTI will be obtained Bed side monitor will be set to display PPV and end tidal CO2 Baxter Starling system will be connected to the patient All baseline values will be recorded Tidal volume will be temporarily adjusted to 8 ml/kg , which will be reverted back to 6ml/kg after the measurements. This has proven to be a safe maneuver.

All the above hemodynamic assessments will be performed for eligible patients by measuring before and after PLR and repositioning to baseline. VTI will be estimated by bed side Echocardiogram. SVI will be estimated using the Starling system (Baxter). PPV and End tidal CO2 will be recorded from the bed side monitors.

Fluid responsiveness is presumed with a change in VTI of 10%. For these patients a mini-fluid challenge of 250 cc of crystalloids (NS, RL or Normosol) will be given over 10 min and PPV, VTI, End tidal CO2 and SVI will be recorded before and after fluid challenge. Patients with VTI change of < 10%, as non-responders, who will also be included in the analysis for assessment of reliability using the ROC curves. hemodynamic assessments and repeated fluid challenge will be considered as needed. Stability of vasopressor dose with maximum of 500 cc of crystalloid will be considered as positive fluid responder. This cohort of patients will be considered as gold standard for preload responsiveness and will be categorized based on a nominal scale. Patients who need higher vasopressor support despite 1L of crystalloid within 3 hours will be considered fluid non-responders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 30 - 90 years
  • Diagnosis of Vasodilatory Shock with no other obvious cause of hypotension
  • Diagnosis of ARDS with PF ratio < 150 , PEEP > 8
  • Patients who are under paralysis or deeply sedated, on a mechanical ventilator

排除标准

  • Patients with arrhythmias including atrial fibrillation
  • Patients with chest tube, intra-abdominal hypertension or with its risk factors
  • Patients with structural heart disease including pulmonary hypertension (RVSP > 45) and heart failure
  • Patients on extracorporeal support such as ECMO, CRRT or MCS.
  • Patients with COPD with a premorbid FEV1 < 1.5 L
  • Severe atherosclerotic vascular disease

结局指标

主要结局

Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min

时间窗: 3 hours after the initial passive leg raise

We shall assess the need for vasopressor dose e.g nor-epinephrine dose. If the dose remains constant after fluid bolus until 3 hours, we shall consider them fluid resposive. If the dose requirement goes up despite fluid bolus, we shall label them fluid un-responsive

次要结局

未报告次要终点

研究者

发起方
CentraCare
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ramakanth Pata

Principal Investigator

CentraCare

研究点 (1)

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