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

Cardiac Output, LIDCO Rapid, Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04705493
• Other study ID #: MD-84-2019
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years.

2. Patients admitted to ICU with septic shock

Exclusion Criteria:

1. Patients with poor Echo window.

2. If they presented with a history of heart failure, valvular disease or arrhythmias.

Related Conditions & MeSH terms

• Cardiac Output, LIDCO Rapid, Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• fluid resuscitation with crystalloid
give two-volume of fluids initial 250ml then another 250 ml

Locations

Country	Name	City	State
Egypt	Kasr El Ainy Shcool of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary outcome	To measure cardiac output difference between LiDCOrapid measurement and echocardiographic measurement .	on patient admission to the icu for 1 hour
Secondary	secondary outcome	to measure dose of vasopressors and inotropic agents	on patient admission to the icu for 1 hour
Secondary	secondary outcome	to measure heart rate	on patient admission to the icu for 1 hour
Secondary	secondary outcome	to measure stroke volume	on patient admission to the icu for 1 hour
Secondary	secondary outcome	to detect stroke volume variation	on patient admission to the icu for 1 hour
Secondary	secondary outcome	to record mean arterial blood pressure	on patient admission to the icu for 1 hour