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Completed

NCT Number: NCT04705493

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

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.

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Key information

Conditions

Cardiac Output, LIDCO Rapid, Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr El Ainy Shcool of Medicine

Cairo, 11211, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fluid resuscitation with crystalloid

Other

give two-volume of fluids initial 250ml then another 250 ml

Primary outcomes

  1. primary outcome

    Time frame: on patient admission to the icu for 1 hour

    To measure cardiac output difference between LiDCOrapid measurement and echocardiographic measurement .

Secondary outcomes

  1. secondary outcome

    Time frame: on patient admission to the icu for 1 hour

    to measure dose of vasopressors and inotropic agents

  2. secondary outcome

    Time frame: on patient admission to the icu for 1 hour

    to measure heart rate

  3. secondary outcome

    Time frame: on patient admission to the icu for 1 hour

    to measure stroke volume

  4. secondary outcome

    Time frame: on patient admission to the icu for 1 hour

    to detect stroke volume variation

  5. secondary outcome

    Time frame: on patient admission to the icu for 1 hour

    to record mean arterial blood pressure

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2021
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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