Comparison Between Using Cardiometry and IVC Collapsibility

Comparison Between Using Cardiometry and IVC Collapsibility in Predicting Fluid Responsiveness in Hypovolemic Sepsis Patients

Sepsis is a life-threatening condition caused by a dysregulated host response to infection, leading to organ dysfunction. Septic shock, a severe form of sepsis, is characterized by persistent hypotension and cellular/metabolic abnormalities despite adequate fluid resuscitation. It is associated with high mortality rates globally, necessitating timely diagnosis and treatment. Fluid resuscitation and vasopressor use are cornerstones of management, but they must be tailored to the individual to prevent complications such as fluid overload.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Procedure: Cardiometry

Detailed Description

Predicting fluid responsiveness in critically ill patients is crucial to optimizing fluid therapy. Traditional static measures like central venous pressure (CVP) are unreliable, while dynamic indices such as stroke volume variation (SVV) and pulse pressure variation (PPV) are considered more accurate but limited to specific conditions. Novel, non-invasive tools for predicting fluid responsiveness are particularly valuable in heterogeneous patient populations, including those with spontaneous breathing or arrhythmias.

Non-invasive cardiometry, utilizing advanced hemodynamic monitoring technologies, offers another method to assess fluid responsiveness. By measuring parameters such as stroke volume and cardiac output, non-invasive cardiometry provides real-time insights into a patient's hemodynamic status without the need for invasive procedures. This approach has the potential to guide fluid management effectively, especially in critically ill patients where invasive monitoring may pose additional risks.

Electrical cardiometry (EC) was introduced as a new bio impedance method with the new algorithm for processing the impedance signal to overcome the limitations associated with bio impedance which are used to measure and calculate hemodynamic parameters as cardiac output, cardiac index, SV and systemic vascular resistance index.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Ahmed Mohamed Fared, MSc; Phone Number: +201005305140; Email: ahmedm.fared9@gmail.com
• Study Contact Backup: Name: Mohamed Fathy Abdelaziz, Lecturer; Phone Number: +201002209632; Email: Dr_mohamed_fathy251@yahoo.com

Study Locations

• Egypt
  • Menoufia
    • Shibīn al Kawm, Menoufia, Egypt, 23511
      • Recruiting
      • Menoufia University Hospital
      • Contact: Noha Abdallah Afify, Professor; Phone Number: +201069113014; Email: nohaafify2014@gmail.com
      • Contact: Marwa Abdelmonem Abdallah, Lecturer; Phone Number: +201092646406; Email: marwamarwamarwa88@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study protocol approval prior to implementation of the research will be obtained from Faculty of Medicine, Menoufia University Research Ethics Committee. Parents were informed about the study purpose and its consequences, confirming confidentiality of data. A signed informed consent was a pre-requisite for the study.

Type of study:

Prospective study

Site of study:

This study will be conducted at the Intensive Care Unit, Faculty of Medicine, Menoufia university Hospital.

The study population:

The study will include (60) septic Shock patients who admitted to Intensive Care Unit.

Description

Inclusion Criteria:

• Patients Diagnosed with Hypotensive Sepsis: Patients must meet the clinical criteria for sepsis according to the Sepsis-3 definitions, including evidence of infection and hypotension despite adequate fluid resuscitation. Hypotension is defined as systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <65 mmHg.
• BMI ≥18.5 and ≤40 kg/m²: Patients will be included regardless of BMI, as long as it falls within the normal to overweight/obese range. Extremes of BMI (e.g., <18.5 or >40) may be excluded due to the potential influence on peripheral perfusion measurements.
• American Society of Anesthesiologists (ASA) Physical Status Classification as:

ASA Score I-III: Patients with an ASA physical status score of I (healthy patients), II (mild systemic disease), or III (severe systemic disease) will be included. Patients with ASA IV or V (those with severe systemic disease that is a constant threat to life) will be excluded due to potential confounding factors.

Exclusion Criteria:

- Cardiac Conditions: Significant valvular heart diseases, such as severe mitral or aortic regurgitation, which can affect hemodynamic assessments.

Presence of major cardiac arrhythmias, including atrial fibrillation or frequent ectopic beats, as these can interfere with accurate measurement of fluid responsiveness.

- Renal Considerations: Patients undergoing renal replacement therapy or those with end-stage renal disease, as fluid balance and responsiveness may be altered.

• Pregnancy Hemodynamic changes during pregnancy (e.g., increased cardiac output and altered vascular resistance) differ significantly from septic shock.
• Patients with a body mass index (BMI) greater than 40 kg/m² Obesity can affect the accuracy of non-invasive monitoring techniques with poor window.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Electrical Cardiometry Monitoring; Non-invasive assessment of stroke volume and cardiac output using electrical cardiometry at baseline and after fluid challenge.	Procedure: Cardiometry; Bedside ultrasound measurement of inferior vena cava diameters during the respiratory cycle to calculate the collapsibility index at baseline and after fluid challenge; Other Names: Inferior Vena Cava Ultrasound Assessment
Inferior Vena Cava Collapsibility Assessment Group; Thirty patients with septic shock will undergo bedside ultrasound assessment of the inferior vena cava to measure the collapsibility index for evaluation of fluid responsiveness. Measurements will be performed as part of routine clinical monitoring without any alteration to standard clinical management.	Procedure: Cardiometry; Bedside ultrasound measurement of inferior vena cava diameters during the respiratory cycle to calculate the collapsibility index at baseline and after fluid challenge; Other Names: Inferior Vena Cava Ultrasound Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Septic Shock Evaluation	Assessment of the participants which suffering from Septic Shock by using Inferior Vena Cava Collapsibility and Electrical Cardiometry for assisting the Fluid Responsiveness	Two Hours

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Chair: Noha Abdallah Afify, Professor, Anaesthesia, Intensive Care and Pain Management, Faculty of Medicine, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2025
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic
• Other Study ID Numbers: Cardiometry and IVC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No