Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis

NCT ID: NCT03938220

Last Updated: 2022-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-09-10

Brief Summary

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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

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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).

Conditions

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Electrical Cardiometry Transthoracic Echocardiography Fluid Responsiveness Sepsis Stoke Volume

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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fluid responders

fluid responder if stroke volume increases by \> 10% after the fluid challenge

Electrical Cardiometry

Intervention Type DEVICE

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

Electrical Cardiometry

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Said ElSharkawy

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospitals

Tanta, ElGharbiaa, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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33017/03/19

Identifier Type: -

Identifier Source: org_study_id

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