Electrical CardiometryNCT03938220
Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis
An observational study of Electrical Cardiometry and Transthoracic Echocardiography, run by Tanta University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Electrical Cardiometry, Transthoracic Echocardiography, Fluid Responsiveness
- What is being tested?
- Electrical Cardiometry
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 10 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Adult, Older adult
Study population: This prospective cohort study will be carried out in Tanta University Hospitals at surgical ICU
Who may be able to join
- 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).
Who cannot join
- Other causes of shock
- Previous cardiac disease
- Rhythm other than sinus rhythm or heart rate > 140 beats/min
- Chronic renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Electrical Cardiometry Measurements Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis
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).
Read the 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).
- Conditions
- Electrical Cardiometry, Transthoracic Echocardiography, Fluid Responsiveness, Sepsis, Stoke Volume
- Being tested
- Electrical Cardiometry
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical CardiometryDevice
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 group | Role | What they receive |
|---|---|---|
| fluid responders | fluid responder if stroke volume increases by > 10% after the fluid challenge Receives: Device: Electrical Cardiometry | |
| fluid non responders | fluid responder if stroke volume increases by <= 10% after the fluid challenge Receives: Device: Electrical Cardiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of electrical cardiometry to predict fluid responsiveness.
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).
Measured: 24 hours
Secondary outcomes (1)
Agreement of electrical cardiometry with transthoracic echocardiography in the change of stroke volume before and after fluid challenge.
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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jun 2019
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical CardiometryStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938220
- Sponsor's protocol ID
- 33017/03/19
- Status last verified
- Apr 2022
- First submitted
- 30 Apr 2019
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Electrical Cardiometry Measurements Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis
- ClinicalTrials.gov ID
- NCT03938220
- Acronym / sponsor ID
- 33017/03/19
- Conditions
- Electrical Cardiometry, Transthoracic Echocardiography, Fluid Responsiveness, Sepsis, Stoke Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluid responders | – | Device: Electrical Cardiometryfluid responder if stroke volume increases by > 10% after the fluid challenge |
| fluid non responders | – | Device: Electrical Cardiometryfluid responder if stroke volume increases by <= 10% after the fluid challenge |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This prospective cohort study will be carried out in Tanta University Hospitals at surgical ICU
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- Other causes of shock
- Previous cardiac disease
- Rhythm other than sinus rhythm or heart rate > 140 beats/min
- Chronic renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical CardiometryElectrical 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. | Device | fluid non responders, fluid responders |
Primary outcome
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).
1 secondary outcome
Agreement of electrical cardiometry with transthoracic echocardiography in the change of stroke volume before and after fluid challenge.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
Related trials for Electrical Cardiometry
Recruiting
Electric Cardiometry-Guided Standard Versus Restricted Fluid Therapy In Robotic Prostaectomy
Prostate Cancer, Surgery
RecruitingObservational study
Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children
Circulatory Failure, Shock State
Not yet recruitingObservational study
Prospective Evaluation of Electrical Cardiometry for Hemodynamic Monitoring in COPD Patients Admitted to the Respiratory Intensive Care Unit
Non-invasive Electrical Cardiometry
Not yet recruitingObservational study
Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry
Feeding Intolerance in Preterm, NEC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrical Cardiometry and Transthoracic Echocardiography, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of electrical cardiometry to predict fluid responsiveness. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.