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Clinical Trials/NCT04705493
NCT04705493
Completed
Not Applicable

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

Cairo University1 site in 1 country40 target enrollmentDecember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Output, LIDCO Rapid, Septic Shock
Sponsor
Cairo University
Enrollment
40
Locations
1
Primary Endpoint
primary outcome
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
July 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Magdy Abdelmohsen Elsayed Mohamed

MSC

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • secondary outcome(on patient admission to the icu for 1 hour)

Study Sites (1)

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