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

• ClinicalTrials.gov Identifier: NCT04705493
• Recruitment Status: Completed
• First Posted: January 12, 2021
• Last Update Posted: August 16, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Magdy Abdelmohsen Elsayed Mohamed, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment
Cardiac Output, LIDCO Rapid, Septic Shock	Other: fluid resuscitation with crystalloid

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• 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
• Actual Study Start Date: December 1, 2019
• Actual Primary Completion Date: July 1, 2021
• Actual Study Completion Date: July 1, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
CASE GROUP; 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; give two-volume of fluids initial 250ml then another 250 ml

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The study will be performed on any patient with septic shock admitted to the surgical ICU.

Criteria

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.

Contacts and Locations

Locations

Egypt

Kasr El Ainy Shcool of Medicine

Cairo, Egypt, 11211

Sponsors and Collaborators

Cairo University

More Information

• Responsible Party: Magdy Abdelmohsen Elsayed Mohamed, MSC, Cairo University
• ClinicalTrials.gov Identifier: NCT04705493
• Other Study ID Numbers: MD-84-2019
• First Posted: January 12, 2021
• Last Update Posted: August 16, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Magdy Abdelmohsen Elsayed Mohamed, Cairo University:

cardiac output , LIDCO . Septic shock

Additional relevant MeSH terms:

Shock, Septic; Shock; Pathologic Processes; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation