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出境医 / 临床实验 / Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis

Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis

Study Description
Brief Summary:
The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC) for the noninvasive determination of fluid responsiveness in sepsis and agreement of (EC) compared to transthoracic echocardiography (TTE).

Condition or disease Intervention/treatment
Electrical Cardiometry Transthoracic Echocardiography Fluid Responsiveness Sepsis Stoke Volume Device: Electrical Cardiometry

Detailed Description:

Usual investigations [complete blood count (CBC), C reactive protein (CRP), serum procalcitonin, serum lactate, arterial blood gases (ABG), blood culture, electrocardiogram (ECG) and liver and renal function tests] will be done.

Once the diagnosis of sepsis is definite and the patient develops hypotension, all patients will undergo simultaneous measurement by (EC) using the ICON_ device and (TTE).

Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). Four sensors of (EC) will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of the neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of the anterior axillary line). The ICON continuously displays heart rate, stroke volume, and cardiac output.

Transthoracic echocardiography (TTE) measurements: will be performed by using Philips (CX50 - Extreme edition) equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and velocity time integral (VTI) measured in left ventricle outflow tract (LVOT) from apical 5 chamber view (by pulsed wave Doppler), respectively. The machine's built-in software uses the formula ''(πD2/4) × VTI × HR'' to calculate CO.

Management of sepsis will be done according to surviving sepsis campaign guidelines in 2016 and its update 2018.

Fluid resuscitation will be 30 mL/kg of intravenous infusion of lactated ringer to be given within the first 3 h (≈5 mL/kg/30 min) guided by fluid responsiveness (fluid responder if SV increases by > 10% after the fluid challenge). If the patient becomes fluid non-responder, vasopressor infusion (norepinephrine 0.05-0.3µg/kg/min) will start. The end of the study is when mean arterial blood pressure > 65 mmHg (either by fluid or both fluid and vasopressor).

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Electrical Cardiometry Measurements Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 5, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
fluid responders
fluid responder if stroke volume increases by > 10% after the fluid challenge
Device: Electrical Cardiometry
Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). Four sensors of EC will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of anterior axillary line). The ICON continuously displays HR, SV and CO.

fluid non responders
fluid responder if stroke volume increases by <= 10% after the fluid challenge
Device: Electrical Cardiometry
Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). Four sensors of EC will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of anterior axillary line). The ICON continuously displays HR, SV and CO.

Outcome Measures
Primary Outcome Measures :
  1. Diagnostic accuracy of electrical cardiometry to predict fluid responsiveness. [ Time Frame: 24 hours ]
    Fluid resuscitation will be 30 mL/kg of intravenous infusion of lactated ringer to be given within the first 3 h (≈5 mL/kg/30 min) guided by fluid responsiveness (fluid responder if stroke volume increases by > 10% after the fluid challenge). If the patient becomes fluid non-responder, vasopressor infusion (norepinephrine 0.05-0.3µg/kg/min) will start. The end of the study is when mean arterial blood pressure> 65 mmHg (either by fluid or both fluid and vasopressor).


Secondary Outcome Measures :
  1. Agreement of electrical cardiometry with transthoracic echocardiography in the change of stroke volume before and after fluid challenge. [ Time Frame: 24 hours ]
    Fluid resuscitation will be 30 mL/kg of intravenous infusion of lactated ringer to be given within the first 3 h (≈5 mL/kg/30 min) guided by fluid responsiveness (fluid responder if stroke volume increases by > 10% after the fluid challenge). If the patient becomes fluid non-responder, vasopressor infusion (norepinephrine 0.05-0.3µg/kg/min) will start. The end of the study is when mean arterial blood pressure> 65 mmHg (either by fluid or both fluid and vasopressor).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This prospective cohort study will be carried out in Tanta University Hospitals at surgical ICU
Criteria

Inclusion Criteria:

  • Age from 19 to 65 years old.
  • Clinical criteria of sepsis [acute change in sepsis-related organ failure assessment (SOFA) variables ≥ 2 points consequent to the infection which include: PaO2/FiO2 ratio < 300, Glasgow Coma Scale score < 15, mean arterial pressure (MAP) < 70 mmHg, serum creatinine >1.2 mg/dl or urine output < 0.5 ml/kg/h, serum bilirubin > 1.2 mg/dL, platelet count < 150 X 103 /µl].
  • Developing hypotension (mean arterial blood pressure ≤ 65 mmHg).

Exclusion Criteria:

  • Other causes of shock
  • Previous cardiac disease
  • Rhythm other than sinus rhythm or heart rate > 140 beats/min
  • Chronic renal failure.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Mohammed Said ElSharkawy, Master +201021559948 mselsharkawy@med.tanta.edu.eg

Locations
Layout table for location information
Egypt
Tanta University Hospitals Recruiting
Tanta, ElGharbiaa, Egypt, 31511
Contact: Mohammed Said ElSharkawy    00201021559948    mselsharkawy@med.tanta.edu.eg   
Sponsors and Collaborators
Tanta University
Tracking Information
First Submitted Date April 30, 2019
First Posted Date May 6, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date June 1, 2019
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2019)
Diagnostic accuracy of electrical cardiometry to predict fluid responsiveness. [ Time Frame: 24 hours ]
Fluid resuscitation will be 30 mL/kg of intravenous infusion of lactated ringer to be given within the first 3 h (≈5 mL/kg/30 min) guided by fluid responsiveness (fluid responder if stroke volume increases by > 10% after the fluid challenge). If the patient becomes fluid non-responder, vasopressor infusion (norepinephrine 0.05-0.3µg/kg/min) will start. The end of the study is when mean arterial blood pressure> 65 mmHg (either by fluid or both fluid and vasopressor).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 1, 2019)
Agreement of electrical cardiometry with transthoracic echocardiography in the change of stroke volume before and after fluid challenge. [ Time Frame: 24 hours ]
Fluid resuscitation will be 30 mL/kg of intravenous infusion of lactated ringer to be given within the first 3 h (≈5 mL/kg/30 min) guided by fluid responsiveness (fluid responder if stroke volume increases by > 10% after the fluid challenge). If the patient becomes fluid non-responder, vasopressor infusion (norepinephrine 0.05-0.3µg/kg/min) will start. The end of the study is when mean arterial blood pressure> 65 mmHg (either by fluid or both fluid and vasopressor).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis
Official Title Validation of Electrical Cardiometry Measurements Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis
Brief Summary The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC) for the noninvasive determination of fluid responsiveness in sepsis and agreement of (EC) compared to transthoracic echocardiography (TTE).
Detailed Description

Usual investigations [complete blood count (CBC), C reactive protein (CRP), serum procalcitonin, serum lactate, arterial blood gases (ABG), blood culture, electrocardiogram (ECG) and liver and renal function tests] will be done.

Once the diagnosis of sepsis is definite and the patient develops hypotension, all patients will undergo simultaneous measurement by (EC) using the ICON_ device and (TTE).

Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). Four sensors of (EC) will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of the neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of the anterior axillary line). The ICON continuously displays heart rate, stroke volume, and cardiac output.

Transthoracic echocardiography (TTE) measurements: will be performed by using Philips (CX50 - Extreme edition) equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and velocity time integral (VTI) measured in left ventricle outflow tract (LVOT) from apical 5 chamber view (by pulsed wave Doppler), respectively. The machine's built-in software uses the formula ''(πD2/4) × VTI × HR'' to calculate CO.

Management of sepsis will be done according to surviving sepsis campaign guidelines in 2016 and its update 2018.

Fluid resuscitation will be 30 mL/kg of intravenous infusion of lactated ringer to be given within the first 3 h (≈5 mL/kg/30 min) guided by fluid responsiveness (fluid responder if SV increases by > 10% after the fluid challenge). If the patient becomes fluid non-responder, vasopressor infusion (norepinephrine 0.05-0.3µg/kg/min) will start. The end of the study is when mean arterial blood pressure > 65 mmHg (either by fluid or both fluid and vasopressor).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This prospective cohort study will be carried out in Tanta University Hospitals at surgical ICU
Condition
  • Electrical Cardiometry
  • Transthoracic Echocardiography
  • Fluid Responsiveness
  • Sepsis
  • Stoke Volume
Intervention Device: Electrical Cardiometry
Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). Four sensors of EC will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of anterior axillary line). The ICON continuously displays HR, SV and CO.
Study Groups/Cohorts
  • fluid responders
    fluid responder if stroke volume increases by > 10% after the fluid challenge
    Intervention: Device: Electrical Cardiometry
  • fluid non responders
    fluid responder if stroke volume increases by <= 10% after the fluid challenge
    Intervention: Device: Electrical Cardiometry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 1, 2019)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 5, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age from 19 to 65 years old.
  • Clinical criteria of sepsis [acute change in sepsis-related organ failure assessment (SOFA) variables ≥ 2 points consequent to the infection which include: PaO2/FiO2 ratio < 300, Glasgow Coma Scale score < 15, mean arterial pressure (MAP) < 70 mmHg, serum creatinine >1.2 mg/dl or urine output < 0.5 ml/kg/h, serum bilirubin > 1.2 mg/dL, platelet count < 150 X 103 /µl].
  • Developing hypotension (mean arterial blood pressure ≤ 65 mmHg).

Exclusion Criteria:

  • Other causes of shock
  • Previous cardiac disease
  • Rhythm other than sinus rhythm or heart rate > 140 beats/min
  • Chronic renal failure.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Mohammed Said ElSharkawy, Master +201021559948 mselsharkawy@med.tanta.edu.eg
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03938220
Other Study ID Numbers 33017/03/19
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mohammed Said ElSharkawy, Tanta University
Study Sponsor Tanta University
Collaborators Not Provided
Investigators Not Provided
PRS Account Tanta University
Verification Date March 2021