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Evaluation of Fluid Resuscitation in Shocked Patients by Electrical Cardiometry in Comparison to Transthoracic Echocardiography.

A

Al-Azhar University

Status

Completed

Conditions

Shock
Fluid Resuscitation
Transthoracic Echocardiography
Electrical Cardiometry

Treatments

Device: Assessment of fluid responsiveness by electrical cardiometry

Study type

Observational

Funder types

Other

Identifiers

NCT06075407
0345/2023

Details and patient eligibility

About

The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC) for the noninvasive determination of fluid responsiveness in critically ill shocked patients and agreement of EC compared to transthoracic echocardiography (TTE)

Full description

Electrical cardiometry (EC), based on thoracic electrical bioimpedance, can measure SV continuously and non-invasively. The EC"s working principle of estimation of SV is to utilize changes in thoracic electrical impedance, which is mainly influenced by erythrocyte orientation and peak flow velocity in the ascending aorta throughout the cardiac cycle.

Electrical cardiometry (EC) has been validated to monitor SV and other hemodynamic parameters non-invasively compared to different techniques such as thermodilution technique, transesophageal Doppler echocardiography and cardiac catheterization including critically ill patients, intra-operative settings, in pregnant women, in children with congenital heart diseases, even in obese children

Enrollment

50 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age from 25 to 65 years old.
  • Both sexes.
  • Patients with clinical criteria of shock [mean arterial pressure (MAP) ≤ 65 mmHg and tissue hypoperfusion (ScvO2 <70%, P(cv-a) CO2 ≥6 mmHg, CRT ≥4 s and lactate >2mmol/l).

Exclusion criteria

  • Refusal to sign the consent by a first degree relative.
  • Previous cardiac disease, rhythm other than sinus rhythm or heart rate > 140 beat/min.
  • Renal failure (acute or chronic).

Trial design

50 participants in 2 patient groups

Fluid responder
Description:
All patients will undergo a volume expansion test or fluid challenge according to standard protocol. The volume expansion test will be performed with an intravenous infusion of 0.9% sodium chloride (500mL) within 15 minutes. The patient becomes a fluid responder if SV increases by \> 10% after the fluid challenge.
Treatment:
Device: Assessment of fluid responsiveness by electrical cardiometry
Fluid non-responder
Description:
All patients will undergo a volume expansion test or fluid challenge according to standard protocol. The volume expansion test will be performed with an intravenous infusion of 0.9% sodium chloride (500mL) within 15 minutes. The patient becomes a fluid responder if SV increases by \> 10% after the fluid challenge (21). If the patient becomes a fluid non-responder, vasopressor infusion or inotrope will start.
Treatment:
Device: Assessment of fluid responsiveness by electrical cardiometry

Trial contacts and locations

1

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Central trial contact

Ahmed A Abdelraouf, MSc

Data sourced from clinicaltrials.gov

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