- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03938220
Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis
Validation of Electrical Cardiometry Measurements Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
ElGharbiaa
-
Tanta, ElGharbiaa, Egypt, 31511
- Tanta University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
fluid responders
fluid responder if stroke volume increases by > 10% after the fluid challenge
|
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 (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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33017/03/19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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