Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis
NCT ID: NCT03938220
Last Updated: 2022-05-03
Study Results
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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COMPLETED
25 participants
OBSERVATIONAL
2019-06-01
2021-09-10
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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fluid responders
fluid responder if stroke volume increases by \> 10% after the fluid challenge
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
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous cardiac disease
* Rhythm other than sinus rhythm or heart rate \> 140 beats/min
* Chronic renal failure.
19 Years
65 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Mohammed Said ElSharkawy
Assistant lecturer
Locations
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Tanta University Hospitals
Tanta, ElGharbiaa, Egypt
Countries
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Other Identifiers
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33017/03/19
Identifier Type: -
Identifier Source: org_study_id
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