Validation of Uncalibrated Cardiac Output Measurement With LiDCOrapid in the Resuscitation of Critically Ill Patients With Septic Shock: A Prospective Cross-sectional Study.

Study Overview
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Brief Summary
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Transthoracic echocardiography (TTE) has been used as a reference technique for CO measurement and its accuracy has been adequate for many clinical uses. TTE is painless, safe and non-invasive. Some drawbacks of TTE are being expensive, bulky and needs advanced training. Currently, due to increased interest in minimally invasive hemodynamic monitoring, multiple new methods have become commercially available to assess CO: the arterial pulse aortic flow, bioreactance, and bioimpedance. One of these new devices is LiDCOrapid (LiDCO Ltd, Cambridge, UK). It is a new, minimally invasive monitor which estimates beat-by-beat CO and fluid responsiveness from the arterial waveform. It has been validated after vascular, urological and thoracic surgery and shows good agreement with the PA catheter in swine, in patients with normal left ventricular systolic function and in patients with vasodilatation. However, LiDCO has not yet been validated in patients with septic shock. Therefore, the aim of this study is to validate LiDCOrapid parameters in septic shock patients using TTE derived parameters as the non-invasive reference.

Detailed Description
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Obtaining a patient's cardiac output (CO) could contribute to optimized, safe hemodynamic control. Accurate CO measurements can serve as a guide for resuscitation therapy, catecholamine use, differential diagnosis, and intervention during a circulatory failure. Although the thermodilution technique via a pulmonary artery catheter (PAC) has an invasive and intermittent, it remains the gold standard for CO measurements. Previously monitoring of CO required invasive and costly devices limiting their use to intensive care setting. More recently ultrasound is increasingly being used and offers a range of non-invasive tools to estimate CO. Transthoracic echocardiography (TTE) has been used as a reference technique for CO measurement and its accuracy has been adequate for many clinical uses. TTE is painless, safe and non-invasive. Some drawbacks of TTE are being expensive, bulky and needs advanced training. Currently, due to increased interest in minimally invasive hemodynamic monitoring, multiple new methods have become commercially available to assess CO: the arterial pulse aortic flow, bioreactance, and bioimpedance. One of these new devices is LiDCOrapid (LiDCO Ltd, Cambridge, UK). It is a new, minimally invasive monitor which estimates beat-by-beat CO and fluid responsiveness from the arterial waveform. It has been validated after vascular, urological and thoracic surgery and shows good agreement with the PA catheter in swine, in patients with normal left ventricular systolic function and in patients with vasodilatation. However, LiDCO has not yet been validated in patients with septic shock. Therefore, the aim of this study is to validate LiDCOrapid parameters in septic shock patients using TTE derived parameters as the non-invasive reference.

Official Title
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Validation of Uncalibrated Cardiac Output Measurement With LiDCOrapid in the Resuscitation of Critically Ill Patients With Septic Shock: A Prospective Cross-sectional Study

Conditions
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Cardiac Output, LIDCO Rapid, Septic Shock

Intervention / Treatment
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* Other: fluid resuscitation with crystalloid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. Patients admitted to ICU with septic shock Exclusion Criteria: Patients with poor Echo window. If they presented with a history of heart failure, valvular disease or arrhythmias.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CASE GROUP<br>Lidco rapid examination and echo examination were done to septic shock patients then the passive leg raising test was done and fluid responder cases were given mini fluid challenge and fluid challenge | Other: fluid resuscitation with crystalloid<br>* give two-volume of fluids initial 250ml then another 250 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary outcome | To measure cardiac output difference between LiDCOrapid measurement and echocardiographic measurement . | on patient admission to the icu for 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary outcome | to measure dose of vasopressors and inotropic agents | on patient admission to the icu for 1 hour | 
| secondary outcome | to measure heart rate | on patient admission to the icu for 1 hour | 
| secondary outcome | to measure stroke volume | on patient admission to the icu for 1 hour | 
| secondary outcome | to detect stroke volume variation | on patient admission to the icu for 1 hour | 
| secondary outcome | to record mean arterial blood pressure | on patient admission to the icu for 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac output , LIDCO . Septic shock