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Device

Non-invasive cardiometry for Volume Overload

N/A
Waitlist Available
Led By Mohamed A Gaafar, MBBCh. MSc
Research Sponsored by National Cancer Institute, Egypt
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

Summary

43 patients between 18-60 years presenting with criteria of sepsis (life-threatening organ dysfunction caused by a dysregulated host response to infection, suspected or documented infection and an acute increase ≥2 SOFA \[Sequential Organ Failure Assessment\] points) will be enrolled in our study. Approval of the ethical committee and informed written consent from first degree relatives will be issued. They will be given a full and detailed explanation of the intended study protocol and will be informed about the potential benefits of the development of a successful technique as well as the potential side-effects. To compare the efficacy of non-invasive cardiometry and ultrasound (US) guided inferior vena cava (IVC) collapsibility when assessing the response of septic patients to fluid therapy guidelines of The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); in the first six hours of ICU admission .

Eligible Conditions
  • Volume Overload
  • Tissue Perfusion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Inferior vena cava collapsibility index
Secondary study objectives
Central Venous Pressure
Heart rate
Inferior Vena Cava Collapsibility Index
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Non-invasive cardiometryExperimental Treatment2 Interventions
OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 A technique for the non-invasive determination of SV, CO, cardiac index, stroke index and HR along with other hemodynamic parameters such as preload (Thoracic Fluid Index), afterload and others. The changes of impedance over time are integrated in a complex algorithm that allows to measure CO and the other above-mentioned parameters.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3
2021
N/A
~50
Fujifilm Sonosite M-Turbo C Ultrasound system
2021
N/A
~50

Find a Location

Who is running the clinical trial?

National Cancer Institute, EgyptLead Sponsor
108 Previous Clinical Trials
8,344 Total Patients Enrolled
Mohamed A Gaafar, MBBCh. MScPrincipal InvestigatorNational Cancer Institute - Cairo University
~11 spots leftby Sep 2025