| Condition or disease | Intervention/treatment |
|---|---|
| Electrical Cardiometry Transthoracic Echocardiography Fluid Responsiveness Sepsis Stoke Volume | Device: Electrical Cardiometry |
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 |
| 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 |
| 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.
|
| Ages Eligible for Study: | 19 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Mohammed Said ElSharkawy, Master | +201021559948 | mselsharkawy@med.tanta.edu.eg |
| Egypt | |
| Tanta University Hospitals | Recruiting |
| Tanta, ElGharbiaa, Egypt, 31511 | |
| Contact: Mohammed Said ElSharkawy 00201021559948 mselsharkawy@med.tanta.edu.eg | |
| 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 |
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 |
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 |
|
||||
| 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.
|
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| Study Groups/Cohorts |
|
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| 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 |
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:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 19 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts |
|
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| 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 |
|
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| 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 | ||||